Catheter-related and clinical complications associated with QDOT MICROTM Ablation Catheter.

INTRODUCTION: The QDOT MICROTM Ablation Catheter is a next-generation ablation catheter that allows for high-power ablation up to 90 watts. METHODS: We aimed to assess AE associated with the QDOT MICROTM catheter using the MAUDE database. A MAUDE database search was conducted on May 25, 2024, to capture all AEs (since FDA approval) associated with this ablation catheter. RESULTS: A total of 302 AEs from November 23, 2022, to April 30, 2024, were reported including 148 (49%) catheter-related issues and 154 (51%) clinical complications. Among the catheter-related issues, physical catheter damage (74.3%, n = 110) was most common, followed by communication or display issue (10.8%, n = 16), irrigation issue (9.5%, n = 14), signal issue or artifact (3.4%, n = 5), and inaccurate temperature measurement (2.0%, n = 3). Regarding clinical complications, the most common AE was pericardial effusion (43.5%, n = 67), followed by char formation (11.7%, n = 18), catheter thrombosis (7.1%, n = 11), stroke (7.1%, n = 11), pericarditis (7.1%, n = 11), esophageal complications (6.5%, n = 10), phrenic nerve palsy (3.9%, n = 6), cardiac arrest (3.9%, n = 6), significant AV block (3.9%, n = 6), pulmonary vein stenosis (3.2%, n = 5), coronary artery spasm (1.3%, n = 2), and pulmonary embolism (0.6%, n = 1). There were 11 deaths (five related to esophageal complications, five related to cardiac arrest, and one related to pericardial effusion with cardiac tamponade). CONCLUSION: As high-power ablation strategy with novel ablation catheters is becoming more widely utilized, operators must be aware of potential catheter-related issues and clinical complications that may arise. More data are needed to further evaluate risks of these complications to improve the catheter's safety and efficacy.

Trends and incidence of reported events associated with ureteral stents: an analysis of the food and drug administration's manufacturer and user facility device experience (MAUDE) database.

PURPOSE: Aim of this study is to summarize medical device reports (MDRs) between 2012 and 2022 relating to ureteral stents within the Manufacturer and User Facility Device Experience (MAUDE) database maintained by The Food and Drug Administration (FDA). METHODS: MAUDE was analyzed for all MDRs relating to each FDA-approved ureteral stent. Event descriptions were reviewed and characterized into specific event types. Outcome measures include specific ureteral stent and reported events as detailed by the MDRs. Data is presented as number of specific event/total events. Pooled Relative risk was used to compare data. RESULTS: 2652 reports were retrieved in 10 years and a progressive rise in reported events was recorded. 831/2652 (31%) were reported as injury while 1810/2652 (68%) as malfunction of the ureteral stent and 4 events of death. The most frequently reported adverse events (AEs) were stent break (627/2652: 23%); material problems (384/2652: 14%); calcification (222/2652: 8%); difficulty to insert, advance or remove the device (155/2652: 6%). Bard stents were associated with most material problems (19%), Resonance stents were associated with most difficulty to insert, advance or remove the device (9%) and calcification (15%) while filiform double pigtail stent set were associated with most breakage reports (56%) when compared to the other stents (PRR > 1, p < 0,05). CONCLUSIONS: According to MAUDE database the most frequent complications related to ureteral stents are breakage, material problems, calcification and difficulty to insert/advance/remove the device. As well Resonance ureteral stents seem to be associated with a higher risk of device problems.

A Comprehensive Analysis of Reported Adverse Events and Device Failures Associated with Esophageal Self-Expandable Metal Stents: An FDA MAUDE Database Study.

INTRODUCTION: Esophageal Stents are used to maintain esophageal lumen patency in esophageal strictures caused by intrinsic and/or extrinsic malignancies and the occlusion of concomitant esophageal fistulas. While data on the efficacy and safety of esophageal stents exist, comprehensive evaluation of adverse events is limited. The aim of this study is to investigate the reported adverse events and device failures associated with esophageal self-expandable metal stents (SEMS) using the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: Post-marketing surveillance data for the esophageal SEMSs were analyzed using the FDA's MAUDE database from January 2014 to December 10, 2023. The outcomes of interest were patient-related adverse events and device failures. Statistical analysis was performed using Microsoft Excel 2010 and SPSS. Pooled numbers and percentages were calculated for each adverse event. Continuous variables underwent analysis using a two-tailed student t test, and significance was set to p ≤ 0.05. RESULTS: During the study period, 548 MAUDE reports revealed 873 device failures and 186 patient-related adverse events. The most common device issues were stent activation, positioning, or separation problems (4 n = 403; 46.2%), followed by device detachment or migration (n = 109, 12.5%), and material problems (n = 93, 10.7%). Patient complications included dysphagia/odynophagia (10%), perforation, pain, and bleeding (each 7.6%). The most common device failures in over-the-wire (OTW) stents and through-the-scope (TTS) stents were activation, positioning, or separation problems (TTS: n = 183, 52.6% vs OTW: n = 220, 41.9%). Compared to OTW stents, TTS stents had higher migration and breakage (13.5% vs. 11.8%, p = 0.24), and (9.2% vs. 6.7%, p = 0.08) respectively, while OTW stents had more challenges with stent advancement or removal (5.1% vs. 0.3%, p < 0.001 and 4.6% vs 3.4%, p = 0.19, respectively) and material problems (14.7% vs. 4.6%, p < 0.001). Activation, positioning, and separation problems were the most frequent device failures in fully covered (FC) and partially covered (PC) stents (FC: n = 62, 32.8%, PC: n = 168, 43.5%). FC stents had higher migration rates (20.6% vs 9.8%, p < 0.001), while PC stents exhibited more material problems (17.4% vs. 5.8%, p < 0.001) and difficulties with advancing the stents (6.7% vs. 0%, p < 0.001). CONCLUSION: Our examination showed a prevalence of reported device complications associated with stent activation, positioning, and separation problems. Dysphagia or odynophagia emerged as the most frequently reported patient complication. Furthermore, our analysis, provides insights into TTS vs. OTW and FC vs. PC esophageal SEMSs, enabling endoscopists and manufacturers to better understand adverse events and potentially optimize device design for future iterations.

Adverse Events and Device Failures Associated with Pancreatic Stents: A Comprehensive Analysis Using the FDA's MAUDE Database.

INTRODUCTION: Pancreatic duct stents (PDS) are widely used for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. However, there is a paucity of data regarding the adverse events associated with PDS placement. This study aims to investigate the reported adverse events and device failures related to PDS, utilizing the Manufacturer and User Facility Device Experience (MAUDE) database maintained by the U.S. Food and Drug Administration (FDA). METHODS: Post-marketing surveillance data from January 2013 to December 8, 2023, were extracted from the FDA's MAUDE database to analyze the reports pertaining to the use of commonly used PDS. The primary outcomes of interest were device issues and patient-related adverse events. Statistical analysis was performed using Microsoft Excel 2010, with the calculation of pooled numbers and percentages for each device and patient adverse event. RESULTS: A total of 579 device issues and 194 patient-related adverse events were identified. Device issues were primarily attributed to stent deformation (n = 72; 12.4%), followed by migration of the device into the pancreatic duct or expulsion out of the duct (n = 60; 10.4%), and stent fracture/breakage (n = 55; 9.4%). Among the patient-reported adverse events, inflammation was the most common (n = 26; 13.4%), followed by reports of stents becoming embedded in tissue (n = 21; 10.8%) and stent occlusion/obstruction (n = 16; 8.2%). The most prevalent device failures associated with Advanix stents were material deformation, with perforation (n = 3, 30%) being the most frequently reported adverse event. Concerning Geenen stents, migration or expulsion of the device (n = 34, 16.9%) constituted the most common device-related adverse events, while inflammation (n = 20, 16.7%) was the most frequently reported patient-related issue. For Zimmon stents, migration or expulsion of the device (n = 22, 8.8%) were the most frequently reported device-related problems, whereas perforation (n = 7, 10.9%) and bleeding (n = 7, 10.9%) were the most frequent patient-related adverse events. CONCLUSION: Our findings highlight important device and patient adverse events that endoscopists and referring providers should be aware of before considering pancreatic stent placement.

Maude Abbott: "A Feminine Misfit in an Exclusive Male Environment" and Her Strategies for Success.

Maude Abbott was a pioneering female Canadian physician who became a world authority on medical museums and congenital heart disease. Abbott spent almost all her career in highly sexist, discriminatory work environments. This paper reviews Abbott's life and accomplishments, but, more importantly, analyzes her pathway to success in the masculine world of early 20th-century academic pathology. Abbott, though well-trained as a pathologist, never provided clinical service, but instead worked as museum curator at McGill University. She established the International Association of Medical Museums (predecessor to the International Academy of Pathology), edited its journal, and essentially ran the organization. Abbott, surrounded by influential males, dealt differently with each. In general, she recognized that male doctors believed women lacked the gravitas to lead major initiatives but that she could circumnavigate this supposed impediment by co-leading projects with male counterparts, preferably ones too busy to get in her way. She repeatedly used this approach, and by doing most of the work but sharing credit, succeeded in gaining reputation, accomplishment, and advancement. Abbott's pioneering work on congenital heart disease established her as one of the founders of pediatric pathology, and, overall, her career promoted the entry of women physicians into the pathology profession.

Medical device report analyses from MAUDE: Device and patient outcomes, adverse events, and sex-based differential effects.

Post-market medical device-associated failures and patient problems are reported in Medical Device Reports (MDRs) to the US Food and Drug Administration. Reports are accessible through Manufacturer and User Facility Device Experience (MAUDE), a database including both required and voluntary submissions. We present an overview of >10 million MDRs received from 2011 to 2021. Approximately 92% of reporting issues represent medical device physical or functional failures, categorized from 1704 codes related to medical device integrity or function. ∼8% were coded adverse events (AEs). Patient outcomes are reported via 998 patient codes in 19 medical specialties (cardiovascular, orthopedic, etc.). ∼40% of patient reports indicated "no health consequences"; however, a small number of devices had consistently high AE reports. While overall reports did not exhibit a sex-based dichotomy, ∼9% of the reported AEs occurred more frequently in females, many of which were related to immune effects. The analyses are subject to uncertainties and potential bias based on data available and data selected for analysis. However, such an overview of post-market MDR data, not previously published, fills a gap in understanding medical device issues and patient-based outcomes related to medical device use. Trends identified may be subjects of additional hypotheses, analysis, and research.

Adverse events related to suction electrocautery devices in adenotonsillectomy: Analysis of the MAUDE database.

OBJECTIVE: To identify adverse events (AEs) related to suction electrocautery use during adenotonsillectomy. METHODS: The US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was searched using the terms "suction cautery," "suction electrocautery," "suction Bovie," and "suction coagulator" from January 2014 to December 2023. RESULTS: 165 AE reports were gathered from the MAUDE database medical device reports (MDRs). 36 met inclusion criteria. Patient injuries were found in 22 (61.1 %) reports and device malfunction events were found in 14 (38.9 %) reports. All patient injuries were thermal burns (N = 22, 100 %). Location of burn injuries included the lip (N = 6, 27.3 %), oral commissure (N = 5, 22.7 %), and tongue (N = 4, 18.2 %). The most common cause of an AE was inadequate device insulation (N = 7, 19.4 %). CONCLUSION: The suction electrocautery apparatus may malfunction and cause patient burn injuries. Device failures mainly result from inadequate device insulation, coagulation problems, and detachment of device components. Surgeons must be aware of these potential complications and counsel parents and patients regarding AEs.

Soft tissue injury events associated with neural integrity monitoring endotracheal tubes: A MAUDE database analysis.

OBJECTIVE: Neural integrity monitoring (NIM) endotracheal tubes are widely used to provide intraoperative monitoring of the recurrent laryngeal nerve during certain neck surgeries, especially thyroidectomy, in order to reduce the risk of nerve injury and subsequent vocal fold paralysis. The unique design of NIM tubes and the increased technical skill required for correct placement compared to standard endotracheal tubes may increase the risk of upper aerodigestive tract soft tissue injury. This study aims to describe adverse events related to NIM endotracheal tubes. STUDY DESIGN: Retrospective cross-sectional study. SETTING: The US Food and Drug Administration's MAUDE database (2010-2022); (Manufacturer and User Facility Device Experience). METHODS: The MAUDE database was queried for reports of adverse events that resulted in patient soft tissue injury involving the use of endotracheal tubes approved by the Food and Drug Administration. RESULTS: There were 28 reported soft tissue injuries, with all events being related to the NIM EMG family of endotracheal tubes manufactured by Medtronic Xomed, Inc. Overall, 24 were categorized as device-related adverse events, and 4 were unspecified in the event description. The most common soft tissue injuries were edema (n = 7) and perforation (n = 7), each accounting for 25 % of adverse events. The second most common injury type was laceration (n = 4), representing 14 % of all adverse events. Overall, 9 patients (32 %) in our cohort required a surgical intervention to treat their injuries, which consisted of 6 tracheotomies and 3 instances of suture repair. CONCLUSIONS: The most commonly reported types of soft tissue injury included edema and perforation, followed by laceration. Increased awareness of device-related patient injuries associated with NIM endotracheal tubes can be used to better inform surgeons and anesthesiologists during the process of intubation and surgical decision-making.

Adverse events associated with Vibrant Soundbridge: A MAUDE study.

OBJECTIVE: To summarize adverse events and their root causes reported to the United States Food and Drug Administration (FDA) on Vibrant Soundbridge (VSB) hearing device (Med-El, Innsbruck, Austria), an active middle ear implant for patients with moderate to severe hearing loss. MATERIALS AND METHODS: The FDA's Manufacturer and User Facility Device Experience (MAUDE) database was queried for reports of VSB adverse events from January 1, 2012, to July 27, 2022. RESULTS: Six hundred sixty-three total medical device reports were identified, from which 913 adverse events were extracted. Of these, 498 (54.5 %) were adverse events to patients (AEPs), while 415 (45.5 %) were device malfunctions (DMs). The most common AEPs were hearing performance issues 428 (85.9 %). The most common DMs were compromised conductive link 125 (30.1 %). Root causes identified for DMs were iatrogenic 85 (58.6 %), patient-related 28 (19.3 %), and trauma and external causes 32 (22.1 %). The most common iatrogenic root cause 12 (14.1 %) involved damage to the conductive link during revision surgery. The most common patient-related causes of DMs were excessive middle ear tissue growth 16 (57 %), and abrupt body movements 5 (28.6 %). The most common external cause of DM was cleaning of the ear canal or mastoid cavity 20 (62.5 %). CONCLUSIONS: Despite its well-known limitations, the MAUDE database provides valuable information on possible complications of VSB as it relates to device malfunction or adverse events for patients. Implementation of standardized reports with relevant and well-defined categories could certainly allow for a more meaningful analysis.

Nasal Epistaxis Balloons: A Comprehensive MAUDE Database Analysis.

BACKGROUND: While nasal epistaxis balloons are generally seen as safe and routinely utilized by both surgical and nonsurgical providers, the complication profile related to this type of device has not been well defined. OBJECTIVE: The objective of this study was to utilize the FDA MAUDE (Manufacturer and User Facility Device Experience) database to better assess adverse events (AE) related to use of nasal epistaxis balloons. Reports were individually tabulated and events were categorized with special attention to AEs. METHODS: The FDA MAUDE database was queried for all medical device reports (MDR) related to nasal epistaxis balloon devices from January 2012 to November 2022. RESULTS: 19 MDRs met inclusion criteria. 5 MDRs were classified as device related (26.3 %); two events were reported for balloon leak and deflation, two events were reported for device breakage, and one device related event was unknown. 14 MDRs (73.7 %) were classified as patient related. Two documented MDRs were patient deaths due to exsanguination. Additional serious AEs included balloon ingestion and subsequent small bowel perforation (n = 1), cerebrospinal fluid leak (n = 1), skull base violation and intracranial placement of the device (n = 1), and respiratory distress (n = 3). CONCLUSION: Though epistaxis control with nasal balloons is generally seen as a safe procedure, there have been several concerning AEs reported. While two reports of death due to exsanguination were the most severe AEs, multiple other life-threatening AEs were also documented. Increased awareness of associated complications can be used to better counsel patients during the informed consent process as well as providers in their clinical decision making.

Adverse events associated with device assisted hyoid and tongue base suspension for obstructive sleep apnea.

PURPOSE: Hyoid and tongue base suspension may treat obstructive sleep apnea (OSA). This study summarizes device-related adverse events associated with the AIRvance and AIRLIFT systems used for hyoid and tongue base suspension. MATERIALS AND METHODS: The U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database was queried for reports describing adverse events associated with hyoid or tongue base suspension from January 2012 to December 2022. RESULTS: 77 adverse events were identified. When performed separately, adverse events were equally as common with hyoid suspension as with tongue base suspension. More complications occurred postoperatively (51 [66.2 %]) than intraoperatively (26 [33.8 %]). The most reported adverse events were infection (23 [29.9 %]), broken screw (15 [19.5 %]), pain or discomfort (10 [13.0 %]), suture rupture (8 [10.4 %]), and dislodged screw (7 [9.1 %]). 10 infections required drainage or debridement; 12 required device explantation. CONCLUSIONS: The present study is the largest and most longitudinal review of adverse events associated with hyoid and tongue base suspension. Infection was the most common adverse event, and may require device explantation. While adverse events were most frequently attributed to device malfunction, broken screw, suture rupture, and broken needle were often attributed to operator error due to application of excessive force. Surgeon training to increase familiarity with hyoid and tongue base suspension may reduce adverse events caused by operator error. The MAUDE database is limited as a passive surveillance system. Standardized reporting may improve understanding of associated adverse events, enabling better informed comparisons between surgical treatment options for OSA.

Adverse events related to robotic-assisted knee arthroplasty: a cross-sectional study from the MAUDE database.

BACKGROUND: Robotic-assisted surgical technique has been clinically available for decades, yet real-world adverse events (AEs) and complications associated with primary knee arthroplasty remain unclear. METHODS: In March 2023, we searched the FDA website and extracted AEs related to robotic assisted knee arthroplasty (RAKA) from the MAUDE database over the past 10 years. The "Brand Name" function queried major robotic platforms, including active and semi-active systems. The overall incidence of AEs was estimated based on annual surgical volume from the current American Joint Replacement Registry (AJRR). Two authors independently collected data on event date, event type, device problem, and patient problem. RESULTS: Of 839 eligible reports, device malfunction comprised mechanical failure (343/839, 40.88%) and software failure (261/839, 31.11%). For surgical complications, inappropriate bone resection (115/839, 13.71%) was most frequent, followed by bone/soft tissue damage (83/839, 9.89%). Notably, over-resection exceeding 2 mm (88/839, 10.49%), joint infection (25/839, 2.98%), and aseptic loosening (1/839, 0.12%) were major complications. Only two track pins related AEs were found. Moreover, the distribution of these AEs differed substantially between robot manufacturers. According to the AEs volume and AJRR data, the overall incidences of AEs related to RAKAs were calculated with 0.83% (839/100,892) between November 2010 and March 2023. CONCLUSION: Our analysis shows that while reported AEs might be increasing for RAKAs, the overall rate remains relatively low. Reassuringly, device malfunction was the most commonly AEs observed, with a minor impact on postoperative outcomes. Furthermore, our data provide a benchmark for patients, surgeons, and manufacturers to evaluate RAKA performance, though continued improvement in reducing serious AEs incidence is warranted.

Automated insulin delivery: benefits, challenges, and recommendations. A Consensus Report of the Joint Diabetes Technology Working Group of the European Association for the Study of Diabetes and the American Diabetes Association.

A technological solution for the management of diabetes in people who require intensive insulin therapy has been sought for decades. The last 10 years have seen substantial growth in devices that can be integrated into clinical care. Driven by the availability of reliable systems for continuous glucose monitoring, we have entered an era in which insulin delivery through insulin pumps can be modulated based on sensor glucose data. Over the past few years, regulatory approval of the first automated insulin delivery (AID) systems has been granted, and these systems have been adopted into clinical care. Additionally, a community of people living with type 1 diabetes has created its own systems using a do-it-yourself approach by using products commercialised for independent use. With several AID systems in development, some of which are anticipated to be granted regulatory approval in the near future, the joint Diabetes Technology Working Group of the European Association for the Study of Diabetes and the American Diabetes Association has created this consensus report. We provide a review of the current landscape of AID systems, with a particular focus on their safety. We conclude with a series of recommended targeted actions. This is the fourth in a series of reports issued by this working group. The working group was jointly commissioned by the executives of both organisations to write the first statement on insulin pumps, which was published in 2015. The original authoring group was comprised by three nominated members of the American Diabetes Association and three nominated members of the European Association for the Study of Diabetes. Additional authors have been added to the group to increase diversity and range of expertise. Each organisation has provided a similar internal review process for each manuscript prior to submission for editorial review by the two journals. Harmonisation of editorial and substantial modifications has occurred at both levels. The members of the group have selected the subject of each statement and submitted the selection to both organisations for confirmation.

Adverse events associated with AveirTM VR leadless pacemaker: A Food and Drug Administration MAUDE database study.

BACKGROUND: Leadless pacemaker (LP) offers an innovative approach for treating bradyarrhythmia, thus avoiding pacemaker pocket and lead-related complications. The Food and Drug Administration (FDA) has recently approved the Aveir™ leadless pacing system (screw-in type LP). METHODS: We queried the FDA MAUDE database to study the safety profile and assess the types of complications with this relatively novel device technology. A MAUDE database search was conducted on January 20, 2023, for reports received post-FDA approval to capture all adverse events. RESULTS: A total of 98 medical device report were reported for Aveir™ LP. After excluding duplicate, programmer-related, or introducer-sheath-related entries (n = 34), 64 entries were included. The most commonly encountered problem was high threshold/noncapture (28.1%, 18 events), followed by stretched helix (17.2%, 11 events) and device dislodgement (15.6%, ten events-5 intraprocedural, while 5 in the postoperative Day 1). Other reported events included high impedance (14.1%, nine events), sensing issues (12.5%, eight events), bent/broken helix (7.8%, five events), premature separation (4.7%, three events), interrogation problem (3.1%, two events), low impedance (3.1%, two events), premature battery depletion (1.6%, one event) and inadvertent MRI mode switch (1.6%, one event) and miscellaneous (15.6%, n = 10). There were eight serious patient injury events-pericardial effusion requiring pericardiocentesis (7.8%, five events) due to cardiac perforation that resulted in two deaths (3.1%) followed by sustained ventricular arrhythmias (4.6%, n = 3). CONCLUSION: In our study assessing the real-world safety profile of the Aveir™ LP, serious adverse events have been reported-life-threatening ventricular arrhythmias, pericardial effusion, device explantation/reimplantation, and death.

Adverse events associated with amplatzer left atrial appendage occlusion delivery system: A Food and Drug Administration MAUDE database study.

BACKGROUND: Dual occlusive closure mechanism (disc and lobe type), Amulet device (Abbott; a second-generation device that has replaced Amplatzer Cardiac Plug) was approved by the Food and Drug Administration (FDA) in August 2021 for percutaneous left atrial appendage occlusion (LAAO). However, real-world safety data on the delivery system (Amplatzer Cardiac Plug and Amplatzer Amulet device) are lacking. OBJECTIVE: We sought to assess the type of adverse events associated with the Amplatzer LAAO delivery system using the FDA Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: A MAUDE database search was conducted on March 31, 2023, for reports received between February 2013 and March 2023 to capture all adverse events. RESULTS: A total of 59 adverse events were reported, of which 58 were sheath-related events, and one was a wire-related event. The most commonly encountered issue was air embolism (19%, 11 events), followed by sheath thrombosis (13.8%, eight events, two of which were also associated with device thrombosis), kinked sheath (10.3%, six events), and sheath deformation (8.6%, five events). Patient-related adverse events included pericardial effusion requiring pericardiocentesis (22.4%, 13 events), vascular complications (20.7%, 12 events), and device dislodgement (5.2%, three events). CONCLUSION: LAAO-related adverse events are increasingly being reported using the Amplatzer LAAO delivery sheath. It is anticipated that improvements in device technology, the advent of steerable sheaths, and operator experience will minimize these complications.

Insights From the FDA's MAUDE Database Regarding the Real-World Safety of Jetstream Atherectomy for Peripheral Arterial Disease.

INTRODUCTION: Rotational atherectomy has shown promise as an adjunctive therapy to percutaneous transluminal angioplasty (PTA) and stenting for the treatment of peripheral arterial disease (PAD). However, published data regarding the safety of these devices are limited. The Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database collects reports of adverse event for medical devices. We present 3 years of MAUDE adverse events data for the Jetstream Atherectomy System (Boston Scientific) for the treatment of PAD. MATERIALS AND METHODS: We searched MAUDE from January 1, 2019 to December 31, 2021. Duplicate reports and those with insufficient information were excluded, leaving a total of 500 reports for analysis. Adverse events were categorized as either patient complication, device malfunction, or both. Adverse events were classified using the Cardiovascular and Interventional Radiological Society of Europe's (CIRSE) classification system for adverse events. RESULTS: The most common patient complications were embolism (22; 4.4%), dissection (17; 3.4%), vessel perforation (12; 2.4%), and device fracture in the patient (6; 1.2%). The most common modes of device failure were entrapment of the device on the guidewire (134; 27%), loss of blade rotation (116; 23%), loss of aspiration (99; 20%), and mechanical damage (57; 11%). As per the CIRSE adverse events classification, most events had no post-procedural sequelae (475; 95%), followed by those requiring prolonged observation (14; 2.8%), and post-procedural therapy without long-term sequelae (10; 2.0%). One hundred six devices (21%) were returned for manufacturer analysis. CONCLUSION: We highlight important adverse events encountered in real-world practice with the Jetstream Atherectomy System. This analysis provides further understanding of the safety profile and modes of failure of Jetstream, and could help guide improvements in product design and manufacturer-user training. There is greater need for root-cause analysis that can aided by returning devices to the manufacturer. CLINICAL IMPACT: We highlight important adverse events encountered in real-world practice with the Jetstream Atherectomy System. The MAUDE database is useful for capturing and characterizing modes of device failure/malfunction not typically described in conventional clinical studies. This may provide valuable information to help guide improvements in product design and manufacturer-user training. This information could also potentially be useful in helping establish manufacturer and product liability in the setting of medicolegal claims. We hope that by contributing to the growing understanding of the safety profile of the Jetstream Atherectomy System, our study may help physicians and patients come to more informed decisions regarding treatment options for PAD.

Real-World Experience With the Angio-Seal Closure Device: Insights From Manufacturer and User Facility Device Experience Database.

PURPOSE: Angio-Seal (Terumo Medical Corporations, Somerset, New Jersey) device is indicated for femoral arteriotomy closure. Real-world published data on complications are limited. We present 1 year of safety events involving Angio-Seal from the US Food and Drug Administration's post-market surveillance database of Manufacturer and User Facility Device Experience (MAUDE). Steps for managing frequent device-related problems are discussed. MATERIALS AND METHODS: Angio-Seal MAUDE data from November 2019 to December 2020 was classified according to (1) mode of device failure, (2) complication, (3) treatment, and (4) Cardiovascular and Interventional Radiological Society of Europe (CIRSE) adverse event classification system. RESULTS: There were 715 safety events, involving Angio-Seal VIP (93.1%), Evolution (5.7%), STS Plus (1.1%), and sizes 6F (62.5%) and 8F (37.5%). Failure mode involved unrecognized use of a damaged device (43.4%), failed deployment (20.1%), failed arterial advancement (6.3%), detachment of device component (4.9%), failed retraction (3.6%), operator error (1.1%), and indeterminate (20.6%). Of total, 44.8% of events were associated with patient harm. Complications involved minor blood loss (34.1%), hematoma (5.6%), significant blood loss (1.4%), and pseudoaneurysm (1.4%). Of total, 43.3% of cases required manual compression (MC), whereas 8.8% required more advanced intervention. Interventions included surgical repair (49.2%), thrombin injection (9.5%), balloon tamponade (6.3%), covered stent (4.8%), and unspecified (30.2%). Majority of safety events were CIRSE grade 1 (92.0%), followed by grades 2 (3.1%), 3 (4.6%), and 6 (deaths, 0.3%). Minority of devices were returned for manufacturer analysis (27.8%). CONCLUSIONS: The majority of safety events were associated with minor blood loss or local hematoma and could be addressed with MC alone. Most events were attributed to damaged device; however, very few devices were returned to manufacturer for analysis. This should be encouraged to allow for root cause analysis in order to improve safety profile of devices. System-level strategies for addressing barriers to under-reporting of safety events may also be considered. CLINICAL IMPACT: Our study highlights important safety events encountered in real-world practice with Angio-Seal closure device. The MAUDE database captures real-world device malfunctions not typically appreciated in conventional clinical trials. Our study provides valuable insight for clinician-users on anticipating and managing the most common device malfunctions. Additionally, our data provide feedback for manufactures to optimize product design and direct manufacturer user training to improve safety. Finally, we hope that the study promotes system-level strategies that foster reporting of safety events and undertaking of root cause analysis.

Understanding a decade of safety reporting for sacral neuromodulation in the Food and Drug Administration Manufacturer and User Facility Device Experience database.

INTRODUCTION: Over 350 000 sacral neuromodulation (SNM) devices have been implanted since approval by the Food and Drug Administration (FDA) in 1998. SNM technology and clinical applications have evolved, with minimal safety updates after initial trials. We aim to provide an updated overview of real-world SNM safety. These insights will guide informed consent, preoperative counseling, and patient expectation-setting. MATERIALS AND METHODS: The FDA Manufacturer and User Facility Device Experience (MAUDE) database is a repository for medical device safety reports. We performed MAUDE categorical (1/1/98-12/31/10) and keyword (1/1/11-9/30/21) searches for "Interstim." A random sample of 1000 reports was reviewed and categorized by theme. To corroborate our MAUDE database analysis, a legal librarian searched the Public Access to Court Electronic Records (PACER) database, as well as Bloomberg Law's dockets database for all lawsuits related to SNM devices. RESULTS: Our search of the MAUDE database returned 44 122 SNM-related adverse events (AEs). The figure illustrates the prevalence of event categories in the random sample. The largest proportion of reports (25.6%) related to a patient's need for assistance with device use, followed by loss/change of efficacy (19.0%). Interestingly, a fall preceded issue onset in 32% of non-shock pain, 30% of lead/device migration, and 27% of painful shock reports. Our legal search revealed only four lawsuits: one for patient complications after an SNM device was used off-label, one case of transverse myelitis after implant, one for device migration or poor placement, and the fourth claimed the device malfunctioned requiring removal and causing permanent injury. CONCLUSIONS: This review confirms the real-world safety of SNM devices and very low complication rates as seen in the original clinical trials. Our findings indicate that 43.2% (95% confidence interval 40.1%-46.3%) of SNM "complications" are not AEs, per se, but rather reflect a need for improved technical support or more comprehensive informed consent to convey known device limitations to the patient, such as battery life. Similarly, the number of lawsuits is shockingly low for a device that has been in the market for 24 years, reinforcing the safety of the device. Legal cases involving SNM devices seem to relate to inappropriate patient selection-including at least one case in which SNM was used for a non-FDA approved indication-lack of appropriate follow-up, and/or provider inability to assist the patient with utilizing the device after implantation.

FDA MAUDE database reported adverse events on noninvasive body contouring, cellulite treatment, and muscle stimulation from 2015 to 2021.

OBJECTIVE: Noninvasive cosmetic procedures have continued to gain popularity, owing to their short, in-office treatments combined with little to no downtime. These procedures are also highly accessible, even offered at medical spas by nonphysician operators. The coronavirus disease 2019 (COVID-19) pandemic also saw heightened interest in all cosmetic procedures, presumably as social distancing and stay-at-home orders allotted time and space for postop recovery. As the market for these procedures expand, a thorough understanding of potential adverse events is critical for providers to better counsel their patients on risks and expectations when obtaining informed consent. MATERIALS AND METHODS: We employed the Food and Drug Administration (FDA's) Manufacturer and User Facility Device Experience (MAUDE) database (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm), which compiles medical device reports (MDRs) for suspected injuries from device use or malfunction, submitted by manufactures and operators. We focused our query on three main categories: noninvasive body contouring, cellulite treatments, and muscle stimulation therapies that utilize electromagnetic energy. The query was performed in February 2022 using a comprehensive list of product names and manufacturers. RESULTS: The initial search yielded 827 MDRs, which were individually reviewed for duplicate reports or insufficient data. Ultimately, 723 MDRs were analyzed (660 for noninvasive body contouring, 55 for cellulite treatment, and 8 for muscle stimulation). Paradoxical hyperplasia accounted for the majority of MDRs for noninvasive body contouring, while burns and scars were most common for muscle stimulation and cellulite treatments, respectively. Of the 7-year span we surveyed, 2021 accounted for 515 of the 723 total assessed MDRs (71.2%), the majority of which were from cryolipolysis procedures. CONCLUSION: The MAUDE database remains an essential tool to monitor potential adverse events of medical devices, including those utilized for noninvasive, cosmetic procedures. Insight from the MAUDE database can be clinically translated when discussing treatment options with patients, helping to optimize patient safety and satisfaction.

Airway fires in otolaryngologic surgery: A database review.

PURPOSE: An estimated 34 % of reported operating room fires involve the airway. Despite the inherent risks in otolaryngologic surgery, education regarding prevention and management of airway fires is limited in graduate medical training. One contributing factor is a lack of reporting of such rare events in our literature. METHODS: The U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience database was queried for reports of adverse events related to fires occurring during surgical procedures of the airway from January 1, 2010, to March 31, 2020. RESULTS: 3687 reports were identified and 49 unique reports of airway fire were included. Sustained fires were described in 16 (32.7 %) reports and 33 (67.3 %) described transient flares. 2 fires extended beyond the airway and 9 (18.4 %) were noted to have occurred at the start of the case. Fires were reported most commonly during tonsillectomy (n = 22 [44.9 %]), vocal fold excision (n = 5 [10.2 %]), and adenoidectomy (n = 4 [8.2 %]). 46 reports attributed flare initiation to a specific element of the fire triangle. 16 patient and 2 operator injuries were reported. Saline washing was utilized in 7 (14.3 %) cases overall. Patients were extubated immediately in 2 (12.5 %) of the 16 reports of sustained fires. 0 mortalities were reported. CONCLUSION: Airway fires were reported in a variety of upper airway procedures performed regularly by otolaryngologists. The triggering factor that led to fire was identified as a spark or char in about half of the reported cases, and only 2 reports described immediate removal of the endotracheal tube.