RESUMEN
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.
RESUMEN
Purpose: Angiographic equipment is a key component of healthcare infrastructure, used for endovascular procedures throughout the body. The literature on adverse events related to this technology is limited. The purpose of this study was to analyze adverse events related to angiographic devices from the US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database. Methods: MAUDE data on angiographic imaging equipment from July 2011 to July 2021 were extracted. Qualitative content analysis was performed, a typology of adverse events was derived, and this was used to classify the data. Outcomes were assessed using the Healthcare Performance Improvement (HPI) and Society of Interventional Radiology (SIR) adverse event classifications. Results: There were 651 adverse events reported. Most were near misses (67%), followed by precursor safety events (20.5%), serious safety events (11.2%), and unclassifiable (1.2%). Events impacted patients (42.1%), staff (3.2%), both (1.2%), or neither (53.5%). The most common events associated with patient harm were intra-procedure system shut down, foot pedal malfunction, table movement malfunction, image quality deterioration, patient falls, and fluid damage to system. Overall, 34 (5.2%) events were associated with patient death; 18 during the procedure and 5 during patient transport to another angiographic suite/hospital due to critical failure of equipment. Conclusion: Adverse events related to angiographic equipment are rare; however, serious adverse events and deaths have been reported. This study has defined a typology of the most common adverse events associated with patient and staff harm. Increased understanding of these failures may lead to improved product design, user training, and departmental contingency planning.
