Pediatric invasive device utility and harm: a multi-site point prevalence survey.

BACKGROUND AND AIMS: Invasive devices are widely used in healthcare settings; however, pediatric patients are especially vulnerable to invasive device-associated harm. This study aimed to explore invasive device utility, prevalence, harm, and clinical practice across three Australian pediatric tertiary hospitals. METHODS: In 2022-2023, a multi-center, observational, rolling-point-prevalence survey was conducted. Fifty-per-cent of inpatients were systemically sampled by random allocation. Patients with devices were then followed for up to 3-days for device-related complications/failures and management/removal characteristics. RESULTS: Of the 285 patients audited, 78.2% had an invasive device (n = 412 devices), with a median of 1 device-per-patient (interquartile range 1-2), with a maximum of 13 devices-per-patient. Over half of devices were vascular access devices (n = 223; 54.1%), followed by gastrointestinal devices (n = 112; 27.2%). The point-prevalence of all device complications on Day 0 was 10.7% (44/412 devices) and period-prevalence throughout the audit period was 27.7% (114/412 devices). The period-prevalence of device failure was 13.4% (55/412 devices). CONCLUSIONS: The study highlighted a high prevalence of invasive devices among hospitalized patients. One-in-ten devices failed during the audit period. These findings underscore the need for vigilant monitoring and improved strategies to minimize complications and enhance the safety of invasive devices in pediatric hospital settings. IMPACT: A high prevalence of invasive devices among hospitalized patients was reported. Of the 285 patients audited, almost 80% had an invasive device (total 412 devices), with a median of 1 device-per-patient and a maximum of 13 devices-per-patient. The most common devices used in pediatric healthcare are vascular access devices (n = 223; 54.1%), however, 16% (n = 36) of these devices failed, and one-third had complications. The point prevalence of all device complications at day 0 was 10.7% (44 out of 412 devices), with a period prevalence of 27.7% (114 out of 412 devices) throughout the audit period.

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.

Incidence, implications, and management of sense-B-noise failure in subcutaneous cardioverter-defibrillator patients: insights from a large multicentre registry.

AIMS: Subcutaneous implantable cardioverter-defibrillators (S-ICDs) offer potentially distinct advantages over transvenous defibrillator systems. Recent randomized trials showed significantly lower lead failure rates than transvenous ICD. Still, S-ICDs remain associated with the risk of inappropriate shocks (IAS). While previous studies have reported varying causes of IAS, this study explores a rare cause of IAS, referred to as 'sense-B-noise.' It was recently described in case series, but its incidence has not been studied in a large cohort of S-ICD patients. METHODS AND RESULTS: We retrospectively reviewed data from patients implanted with S-ICD models 1010, A209, and A219 between October 2009 and July 2023 across nine centres in Europe and the USA. The analysis concentrated on determining the incidence and understanding the implications of sense-B-noise events. Sense-B-noise represents a rare manifestation of distinct electrogram abnormalities within the primary and alternate sensing vectors. Data were collected from medical records, device telemetry, and manufacturer reports for investigation. This registry is registered on clinicaltrials.gov (NCT05713708). Subcutaneous implantable cardioverter-defibrillator devices of the 1158 patients were analysed. The median follow-up time for all patients was 46 (IQR 23-64) months. In 107 patients (9.2%) ≥1 IAS was observed during follow-up. Sense-B-noise failure was diagnosed in six (0.5 and 5.6% of all IAS) patients, in all patients, the diagnosis was made after an IAS episode. Median lead dwell time in the affected patients was 23 (2-70) months. To resolve the sense-B-noise defect, in three patients reprogramming to the secondary vector was undertaken, and two patients underwent system removal with subsequent S-ICD reimplantation due to low amplitude in the secondary vector. In one patient, the secondary vector was initially programmed, and subsequently, an S-ICD system exchange was performed due to T-wave-oversensing IAS episodes. CONCLUSION: This multicentre analysis' findings shed light on a rare but clinically highly significant adverse event in S-ICD therapy. To our knowledge, we provide the first systematic multicentre analysis investigating the incidence of sense-B-noise. Due to being difficult to diagnose and limited options for resolution, management of sense-B-noise is challenging. Complete system exchange may be the only option for some patients. Educating healthcare providers involved in S-ICD patient care is crucial for ensuring accurate diagnosis and effective management of sense-B-noise issues.

Occurrence of premature battery depletion in a large multicentre registry of subcutaneous cardioverter-defibrillator patients.

AIMS: Subcutaneous implantable cardioverter-defibrillators (S-ICDs) have become established in preventing sudden cardiac death, with some advantages over transvenous defibrillator systems, including a lower incidence of lead failures. Despite technological advancements, S-ICD carriers may suffer from significant complications, such as premature battery depletion (PBD), that led to an advisory for nearly 40 000 patients. This multicentre study evaluated the incidence of PBD in a large set of S-ICD patients. METHODS AND RESULTS: Data from patients implanted with S-ICD models A209 and A219 between October 2012 and July 2023 across nine centres in Europe and the USA were reviewed. Incidence and implications of PBD, defined as clinically observed sudden drop in battery longevity, were analysed and compared to PBD with the definition of battery depletion within 60 months. Prospectively collected clinical data were obtained retrospectively from medical records, device telemetry, and manufacturer reports. This registry is listed on ClinicalTrials.gov (NCT05713708). Of the 1112 S-ICD devices analysed, 547 (49.2%) were equipped with a potentially affected capacitor linked to PBD occurrence, currently under Food and Drug Administration advisory. The median follow-up time for all patients was 46 [inter-quartile range (IQR) 24-63] months. Clinically suspected PBD was observed in 159 (29.1%) of cases, with a median time to generator removal or replacement of 65 (IQR 55-72) months, indicative of significant deviations from expected battery lifespan. Manufacturer confirmation of PBD was made in 91.7% of devices returned for analysis. No cases of PBD were observed in devices that were not under advisory. CONCLUSION: This manufacturer-independent analysis highlights a notable incidence of PBD in patients equipped with S-ICD models under advisory, and the rate of PBD in this study corresponds to the rate currently estimated by the manufacturer. To the best of our knowledge, this provides the largest contemporary peer-reviewed study cohort investigating the actual incidence of PBD in S-ICD patients. These findings emphasize the importance of post-market registries in collaboration between clinicians and the manufacturer to optimize safety and efficacy in S-ICD treatment.

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.

Uncovering the rate and risk factors of intrathecal baclofen pump-associated complications in the adult population.

OBJECTIVE: The aim of this study was 1) to describe the rate of intrathecal baclofen (ITB)-associated complications at a large tertiary center, and 2) to evaluate the impact of patient-related factors on the likelihood of developing such complications. METHODS: A retrospective single-center study was carried out. A total of 301 eligible patients were included in the analysis. Univariate regression models were used to evaluate the impact of age, sex, diagnosis, ambulation status, modified Ashworth scale score, body mass index, diabetes status, and pain level on the likelihood of developing a device-related infection, pump malfunction, catheter malfunction, and other clinically significant complications. RESULTS: Overall, 27% of patients experienced an ITB-related complication. The most common complications included infection (6%, 18/301), pump malfunction (7.3%, 22/301), and catheter malfunction (14%, 42/301). The univariate analyses revealed that the patient's ambulatory status had a significant impact on the likelihood of developing a catheter-related malfunction. Furthermore, a trend toward significance was identified between patients' preoperative body mass index and device-related infection. Finally, the risk of suffering any ITB-related complications was statistically correlated with the number of years that had passed since the initial pump implantation. CONCLUSIONS: The authors' analysis reveals a previously underrecognized association between ambulatory status at the time of ITB pump implantation and the incidence of catheter-related complications, and confirms the impact of time since surgery on the risk of developing any ITB-related complication. The patient's age, sex, diagnosis, diabetes status, or pain level at baseline were not associated with the risk of complications. Collectively, these insights contribute novel information to the existing literature, providing practical value for physicians in guiding patient selection for ITB therapy.

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.

Adverse events associated with anastomotic coupling devices in microvascular reconstruction.

OBJECTIVE: In light of the recent US Food and Drug Administration (FDA) Class 2 safety recall notice for anastomotic coupling devices, it is important to understand related adverse events. The aim of this study was to characterize adverse events in anastomotic coupling devices for microvascular reconstruction. METHODS: A retrospective cross-sectional analysis using the 2011 to 2021 US FDA Manufacturer and User Facility Device Experience (MAUDE) database. All reports of adverse events involving anastomotic coupling devices were retrieved from the MAUDE database. Descriptive statistics were used to analyze categorized events. RESULTS: There were a total of 293 documented adverse events related to anastomotic coupling devices. These adverse events resulted in 91 (31.1 %) patient injuries and 239 (81.6 %) device malfunctions. The most frequent patient problems were thrombosis/hematoma (n = 38; 41.8 %), unspecified injury (n = 31; 34.1 %), and failure to anastomose (n = 13; 14.3 %). Free flap necrosis was reported in 42 % of thrombosis/hematoma cases (n = 16). The most common malfunctions were devices operating differently than expected (n = 74; 31.0 %), connection problems (n = 41; 17.2 %), and twisted/bent material (n = 19; 7.9 %). There was no significant trend in the number of adverse events over the study period (p > 0.05). CONCLUSIONS: Adverse events from anastomotic coupling devices represent an important and modifiable factor in free tissue failure. Adverse events are predominately related to devices operating differently than expected and may result in vascular compromise of the free flap. Reconstructive surgeons should be cognizant of defective anastomotic coupling devices and be prepared to utilize traditional hand-sewn anastomosis.

Prevalence and Predictors of Tunneled Dialysis Catheter Dysfunction.

BACKGROUND: Hemodialysis requires reliable, recurrent access to the circulatory system. Central venous tunneled dialysis catheters (TDC) are frequently used for patients receiving hemodialysis as a bridge to permanent vascular access or as a final option. TDC are prone to complications such as infection and dysfunction. OBJECTIVES: To assess the prevalence and predictors of TDC dysfunction in a cohort of chronic hemodialysis patients. METHODS: This single-center, retrospective study was based on data from an electronic database of chronic hemodialysis patients during 5 years of follow-up. RESULTS: A total of 625 TDC were inserted in 361 patients, of which 234 (37.4%) were replaced due to dysfunction. The main insertion site was the right internal jugular vein. Diabetes mellitus was an important predictor of TDC dysfunction and was significantly correlated with TDC extraction. Chronic anticoagulation and antiplatelet treatment did not affect the rate of TDC dysfunction or replacement. CONCLUSIONS: TDC use for chronic dialysis patients is increasing and dysfunction is a major problem. In our study, we highlighted the high prevalence of TDC dysfunction and the need for further research to improve hemodialysis access as well as TDC patency and function.

Association between time to stent dysfunction and the anti-tumour effect of systemic chemotherapy following stent placement in patients with pancreaticobiliary cancers and malignant gastric outlet obstruction: a retrospective cohort study.

BACKGROUND: Malignant gastric outlet obstruction (MGOO) occasionally occurs due to pancreaticobiliary cancer. Endoscopic duodenal stenting (DS) is a common treatment for MGOO. However, it has been reported that DS does not have sufficient patency time for it to be used in patients who have a potentially increased lifespan. Nowadays, systemic chemotherapy for pancreaticobiliary cancer has developed, and its anti-tumour effect would make time to stent dysfunction longer. Therefore, we retrospectively evaluated the association between objective response to systemic chemotherapy, followed by DS and time to stent dysfunction in patients with advanced pancreaticobiliary cancer. METHODS: This retrospective study included 109 patients with advanced pancreaticobiliary cancer who received systemic chemotherapy after DS. Patients who showed complete or partial response were defined as responders. The rest were defined as non-responders. Time to stent dysfunction was compared between responders and non-responders using the landmark analysis at 2 months after DS. Death without recurrence of MGOO was considered as a competing risk for time to stent dysfunction. RESULTS: Combination and monotherapy regimens were adopted for 46 and 63 patients, respectively. Median progression-free survival and overall survival were 3.2 months (95% confidence interval [CI], 2.4-4.0) and 6.0 months (95% CI, 4.6-7.3). Objective response was observed in 21 patients (19.3%). Median time to stent dysfunction was 12.5 months (95% CI, 8.4-16.5) in the entire cohort. In 89 patients, responders had a lower cumulative incidence of stent dysfunction than non-responders: 9.5 and 19.1% at 6 months, and 19.0 and 27.9% at 1-year, respectively. There was difference of time to stent dysfunction between responders and non-responders among patients who received combination regimen as the first-line treatment with p-value of 0.009: cumulative incidence was 0 and 42.9% at 6 months, and 9.3 and 57.1% at 1-year, respectively. CONCLUSIONS: Longer time to stent dysfunction is expected when systemic chemotherapy following DS suppresses tumour progression; DS is slated to be a standard treatment for MGOO even in patients with pancreaticobiliary cancer and a long lifespan.

Outcomes of the novel Odon Device in indicated operative vaginal birth.

BACKGROUND: No new method of assisting vaginal birth has been introduced into clinical practice since the development of the vacuum extractor in the 1950s. The Odon Device is a new device that employs a circumferential air cuff over the fetal head to assist birth. In this study, the Odon Device has been used to assist vaginal birth for standard clinical indications. OBJECTIVE: This study aimed to investigate the clinical impact, safety, and acceptability of the Odon Device to women, their babies, and clinicians and to assess the feasibility of recruiting women to an interventional intrapartum research study. STUDY DESIGN: This is a nonrandomized, single-arm interventional feasibility study of the Odon Device for operative vaginal birth undertaken in a single maternity unit: Southmead Hospital, Bristol, United Kingdom. The Odon Device was used to assist birth in 40 women who required the birth to be assisted for suspected fetal compromise and/or prolonged second stage of labor. The primary clinical outcome was the proportion of births successfully assisted with the Odon Device, and the primary feasibility outcome was the proportion of eligible women who were approached and who agreed to participate. Neonatal outcome data were reviewed at day 28, and maternal outcomes were investigated up to day 90. RESULTS: Between October 2018 and January 2019, 298 of 384 approached, eligible women (77.6%) consented to participate. Of these women, 40 received the intervention-the use of the Odon Device. Birth was assisted in all cephalic (occiput anterior, occiput transverse, and occiput posterior) fetal positions, at all stations at or below the ischial spine and with or without regional analgesia. The Odon Device was effective in 19 of 40 cases (48%). Of the 40 births, 21 (52.5%) required additional assistance: 18 of 40 births (45%) were completed using nonrotational forceps, 1 of 40 births (3%) required rotational forceps, and 2 of 40 births (5%) required an emergency cesarean delivery. There was no serious maternal or neonatal adverse event related to the use of the device, and there was no serious adverse device effect. There were 4 devices (10%) that were ineffective because of a manufacturing fault. Furthermore, 39 of 40 women (98%) reported a high birth perception score. All practitioners were able to use the device as intended, although some steps in using the device were reported to be easier to perform (setup and deflation of air chamber) than others (application of the device and withdrawal of the applicator). CONCLUSION: Recruitment to an interventional study of a new device for operative vaginal birth was feasible; 78% of eligible women were willing to participate, often expressing an aspiration for an alternative to forceps and vacuum. The success rate of the Odon Device was lower than reported success rates of vacuum and forceps; however, in this study, the device had been used to assist birth for standard clinical indications. There was no significant maternal or neonatal safety concern associated with the use of the device, although the number of births studied was small. Further feasibility study to establish iterative changes to the device, technique, and clinical indications is necessary.

IPAA in Known Preoperative Crohn's Disease: A Systematic Review.

BACKGROUND: Crohn's disease is a relative contraindication to IPAA due to perceived increased rates of pouch failure. OBJECTIVE: This study aimed to determine pouch functional outcomes and failure rates in patients with a known preoperative diagnosis of Crohn's disease. DATA SOURCES: A database search was performed in Ovid Medline In-Process & Other NonIndexed Citations, Ovid MEDLINE, Ovid EMBASE, Ovid Cochrane Central Register of Controlled Trials, and Ovid Cochrane Database of Systematic Reviews. STUDY SELECTION: The published human studies that reported short-term postoperative outcomes and/or long-term outcomes following IPAA in adult (≥18 years of age) Crohn's disease populations were selected. INTERVENTION: Ileal pouch anal anastomoses were constructed in patients who had Crohn's disease diagnosed preoperatively or through proctocolectomy pathology. MAIN OUTCOMES MEASURES: The primary outcomes measured were long-term functional outcomes (to maximal date of follow-up) and the pouch failure rate. RESULTS: Of 7019 records reviewed, 6 full articles were included in the analysis. Rates of pelvic sepsis, small-bowel obstruction, pouchitis, anal stricture, and chronic sinus tract were 13%, 3%, 31%, 18%, and 28%. Rates of incontinence, urgency, pad usage in the day, pad usage at night, and need for antidiarrheals were 24%, 21%, 19%, 20%, and 28%, and mean 24-hour stool frequency was 6.3 bowel movements at a mean 69 months of follow-up. The overall pouch failure rate was 15%; no risk factors for pouch failure were identified. LIMITATIONS: This investigation was limited by the small number of studies with significant study heterogeneity. CONCLUSION: In patients with known preoperative Crohn's disease, IPAA construction is feasible with functional outcomes equivalent to patients with ulcerative colitis, but, even in highly selected patients with Crohn's disease, pouch failure rates remain higher than in patients with ulcerative colitis.

Endotracheal Tube Obstruction Among Patients Mechanically Ventilated for ARDS Due to COVID-19: A Case Series.

BACKGROUND: Patients with COVID-19 and ARDS on prolonged mechanical ventilation are at risk for developing endotracheal tube (ETT) obstruction that has not been previously described in patients with ARDS due to other causes. The purpose of this report is to describe a case series of patients with COVID-19 and ARDS in which ETT occlusion resulted in significant clinical consequences and to define the pathology of the obstructing material. METHODS: Incidents of ETT occlusion during mechanical ventilation of COVID-19 patients were reported by clinicians and retrospective chart review was conducted. Statistical analysis was performed comparing event rates between COVID-19 and non-COVID 19 patients on mechanical ventilation over the predefined period. Specimens were collected and submitted for pathological examination. FINDINGS: Eleven COVID-19 patients experienced endotracheal tube occlusion over a period of 2 months. Average age was 69 (14.3, range 33-85) years. Mean APACHE III score was 73.6 (17.3). All patients had AKI and cytokine storm. Nine exhibited biomarkers for hypercoagulability. Average days on mechanical ventilation before intervention for ETT occlusion was 14 (5.18) days (range of 9 to 23 days). Five patients were discharged from the ICU, and 4 expired. Average documented airway resistance on admission was 14.2 (3.0) cm H2O/L/sec. Airway resistance before tube exchange was 28.1 (8.0) cm H2O /L/sec. No similar events of endotracheal tube occlusion were identified in non-COVID patients on mechanical ventilation during the same time period. Microscopically, the material consisted of mucin admixed with necrotic cell debris, variable numbers of degenerated inflammatory cells, oral contaminants and red blood cells. INTERPRETATION: Patients with COVID-19 and ARDS on prolonged mechanical ventilation are at risk for developing ETT obstruction due to deposition of a thick, tenacious material within the tube that consists primarily of mucin and cellular debris. Clinicians should be aware of this dangerous but treatable complication.

Adverse events associated with Bonebridge and Osia bone conduction implant devices.

PURPOSE: Active transcutaneous Bone Conduction Implants (BCIs) are relatively new to the market and may offer improved outcomes while reducing skin-related complications associated with previous models. The purpose of this study is to examine medical device reports (MDRs) submitted to the Food and Drug Administration's (FDA) Manufacturer and User Device Facility Experience (MAUDE) database to identify adverse events with the active, transcutaneous BCIs, Bonebridge and Osia. METHODS: A search of the FDA MAUDE database was conducted using product code "PFO" (for Active Implantable Bone Conduction Hearing System), brand names "Bonebridge" and "Osia." Data was collected on device malfunction, patient injury, inciting events, and subsequent interventions between July 1, 2018 and November 1, 2020. RESULTS: The search query yielded 83 reports that met inclusion criteria, 56 regarding Bonebridge and 27 regarding Osia. A total of 91 adverse events were reported, including 45 device malfunctions and 46 patient injuries. Of all adverse events reported for Bonebridge, 15 (26.3%, 15/57) documented patient injuries, while the majority (73.7%, 42/57) documented device malfunctions. Of all adverse events reported for Osia, 3 (8.8%, 3/34) were reported concerning malfunctions, while 31 (91.2%, 31/34) were reported for patient injuries. The most commonly reported adverse events included lack of conduction or hearing (n = 26, 28.6%), infection (n = 14, 15.4%), and intermittent or reduced conduction or hearing (n = 12, 13.2%). From the MAUDE database reported adverse events and the total number of Osia implants given to us from Cochlear over this 28 month period, we estimate patient injuries to occur in roughly 2.1% of patients. CONCLUSION: There are limitations to the database which make systemic analysis challenging. This study suggests that patients with transcutaneous, active BCIs may be experiencing fewer soft tissue injuries, but similar device malfunctions as those with previous models.

Complications associated with PlasmaBlade TnA during tonsillectomy and adenoidectomy from 2010 to 2020: A MAUDE study.

PURPOSE: The pulsed-electron avalanche knife (PEAK) PlasmaBlade TnA (Medtronic, n.d.) is a relatively new electrosurgical technology that is used widely in head and neck surgery (Medtronic Manuals, n.d.). This study aims to summarize device malfunctions, patient complications, and subsequent interventions related to PEAK PlasmaBlade TnA during tonsillectomy and adenoidectomy. MATERIALS AND METHODS: The US Food and Drug Administration's Manufacture and User Facility Device Experience database was queried for reports of PlasmaBlade TnA adverse events from June 6, 2009, to August 30, 2020. Data were extracted from reports pertaining to tonsillectomy with or without adenoidectomy. RESULTS: 128 reports were identified, from which 163 adverse events were extracted. Of these, 23 (14.6%) were related to patients, and 140 (85.4%) were related to device malfunction. The most frequently reported patient-related adverse event was a burn injury (17 [73.9%]). The most common device malfunctions were dislodgment of device component (39 [27.9%]), followed by tip ignition (32 [22.9%]), damaged tip or wire during operation (28 [20%]), and melted device (24 [17.1%]). CONCLUSIONS: PEAK PlasmaBlade TnA have demonstrated utility in tonsillectomy with or without adenoidectomy but are associated with adverse events. Interventions aimed at improving both physician and patient education may help reduce adverse events attributed to improper use. Further study is needed to clarify optimal approaches to education.

Risk events during intrahospital transport of patients from the emergency department: a prospective observational study.

BACKGROUND: We aimed to determine the incidence, nature of and predisposing factors for risk events (REs) that occur during the intrahospital transport of patients from the ED. METHODS: We undertook a prospective, observational study of intrahospital patient transports from a single ED between 30 January and 20 March 2020. An investigator attended each transport and recorded any RE on a specifically designed data collection document. An RE was any mishap, even if not foreseen, that had the potential to cause the patient harm. A patient equipment number was assigned based on the number of pieces of equipment required during the transport. Poisson regression generated incidence rate ratios (IRRs) and determined risk factors for REs. RESULTS: Of 738 transports, 289 (39.1%, 95% CI 35.6% to 42.8%) had at least one RE. The total of 521 REs comprised 125 patient-related, 279 device-related and 117 line/catheter-related REs. The most common included trolley collisions (n=142), intravenous fluid line catching/tangling (n=93), agitation/aggression events (n=31) and cardiac monitoring issues (n=31). Thirty-four (6.5%) REs resulted in an undesirable patient outcome, most commonly distress and pain. Predisposing factors for REs included an equipment number ≥3 (IRR 5.68, 95% CI 3.95 to 8.17), transport to a general ward (IRR 2.68, 95% CI 2.12 to 3.39), hypertension (IRR 1.93, 95% CI 1.07 to 3.50), an abnormal temperature and a GCS<14. CONCLUSIONS: REs are common in transport of patients from the ED and can result in undesirable patient outcomes. Adequate pre-transfer preparation, especially securing equipment and lines, would result in a reduced risk.

Unexpected tunnelled central venous access demise: a single institutional study from the UK.

PURPOSE: To explore the factors involved in the demise of tunnelled central vascular access devices (CVADs) in children and describe patterns of failure. METHODS: A retrospective study including children under 16 years of age undergoing CVAD insertion in a tertiary centre between October 2014 and December 2019. The Kaplan-Meier estimator was used to study CVAD survival and piecewise exponential curves to approximate hazard rates. Related factors were analysed using multivariable regression. RESULTS: Totally, 684 CVADs were inserted in 499 children. Devices were in situ for 213,821 days (median 244.5). Of those, 261 CVADs (38.2%) failed prematurely; 176 (67%) required replacement. Tunnelled external lines (TELs) failed more frequently than totally implantable devices (p < 0.005).TEL displacement occurred in two high-risk phases, falling to baseline after 90 days. Low age at device insertion and open placement were strongly associated with an increased failure rate. Previous CVAD failure did not increase subsequent failure rate. Premature failure increased procedural cost by £153,949 per year. CONCLUSIONS: TIDs should be placed in preference to TELs where appropriate. TELs are at highest risk of displacement for 90 days and must be well secured for this duration. Meticulous line care offers significant potential cost savings by reducing line replacements. LEVEL OF EVIDENCE: Level III.

Protective Dressings, Injury, and Device Failure in Preterm Infants Receiving Nasal Continuous Positive Airway Pressure: A Randomized Controlled Trial.

OBJECTIVE: To investigate the protective effect of a hydrocolloid nasal dressing on the incidence and severity of nasal injury and continuous positive airway pressure (CPAP) failure in preterm infants receiving nasal CPAP (N-CPAP). METHODS: A randomized controlled trial was conducted over 4 months in 2019 at level 3 neonatal ICUs in two hospitals affiliated with Isfahan University of Medical Sciences, Iran. Eighty eligible infants were born at 32 weeks of gestation or younger and/or with a birth weight of 1,500 g or less and had received between 4 and 72 hours of CPAP. Infants were randomly assigned to two groups; the intervention group used a protective dressing, and the control group received routine care. Data collection tools included a demographic questionnaire and nasal injury assessment score chart. MAIN OUTCOME MEASURES: The incidence and severity of nasal injury in preterm infants undergoing N-CPAP. RESULTS: Infants in the intervention group had a significantly lower incidence and severity of nasal injury compared with the control group: 15 of 40 (37.5%) versus 37 of 40 (92.5%; P < .001). Overall, the injuries identified in this study were mostly mild and moderate, with only three severe injuries in the intervention group and five in the control group. No significant differences were detected in CPAP failure (P > .05). CONCLUSIONS: The studied nasal barrier dressing is a safe and convenient solution to reduce nasal injury in preterm infants receiving N-CPAP.

Tampon loss - management among adolescents and adult women.

The widespread use of tampons carries a risk of tampon loss due to imperfect use. We performed a retrospective study including all women attending the emergency room (ER) with the complaint of tampon loss during 2011-2018. Overall, 72 women presented to the ER with a complaint of tampon loss. In 25% (18/72), a lost tampon was found on physical examination. The lost tampon was found in a higher rate among adolescents as compared to older women (4 (80%) vs. 14 (21%), 15.1, p = .01). Time from tampon loss to referral for evaluation was shorter among adolescents as compared to older women (7 ± 3 vs. 21 ± 21 h, p = .007). In most adolescents with a complaint of a lost tampon - it was eventually found on pelvic examination, as opposed to older women, in whom a finding was present in only one-fifth of cases. This highlights the importance of thorough examination of adolescents presenting due to tampon loss. The study protocol was approved by the Sheba Medical Center review board (March 15, 2018), 6345-19-SMC.IMPACT STATEMENTWhat is already known on this subject? Very little is known regarding the distinguished phenomena of tampon loss among adult females.What do the results of this study add? In most adolescents referred due to tampon loss - a tampon was found on pelvic examination, as opposed to older women.What are the implications of these findings for future clinical practice and/or further research? In most adolescents referred due to tampon loss - a tampon will be found on pelvic examination, as opposed to older women, in whom a finding is present in only one-fifth of cases. This highlights the importance of thorough examination of adolescents presenting with a loss of tampon.

Prevalence and characteristics of shunt malfunction without ventricular size change at King Abdulaziz Medical City in Riyadh.

OBJECTIVES: To determine the prevalence of shunt malfunction without change in ventricle size in imaging modalities, and its clinical presentation. METHODS: A cross-sectional study conducted at King Abdulaziz Medical City, Riyadh, from June 2015 to May 2019. Patient's demographics, clinical presentation and changes in ventricle size were collected. Statistical analysis was done using SPSS version 23. RESULTS: The study included 42 patients who underwent shunt revision. Imaging showed no change in size in 10 (24%) patients, mild enlargement in 8 (19%), and obvious enlargement in 24 (57%). The mean age of diagnosis was 22±16.7. 55% of the patients were males, 45% females. The cause of the malfunction was ventricular catheter occlusion in 14 (34%) patients, 10 (24%) patients had valve-related malfunction, and peritoneal catheter occlusion was present in 6 (14%) patients, and 12 (28%) patients had a combination of the previously mentioned causes. Analysis of the association between ventricular size and headache, vomiting, seizure, confusion, and loss of consciousness in patients with unchanged ventricular size and those with increased ventricular size has shown no statistical significance. CONCLUSION: Shunt malfunction without ventricular size change was observed in 24% of all shunt malfunction patients. In addition, there was no relationship between ventricular size and patient symptoms.