Clinical Adverse Events and Device Failures Reported for the Captivator and Duette Endoscopic Mucosal Resection (EMR) Systems

Abstract

Introduction: Endoscopic mucosal resection (EMR) is a widely used technique for the removal of precancerous or select cancerous mucosal-based lesions. Two systems used for EMR of upper gastrointestinal lesions are the Duette EMR kit and the Captivator EMR kit. The aim of this study is to analyze the reports submitted to the Food and Drug Administration’s (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for patient-related adverse events and device failures associated with these EMR kits. Methods: We analyzed postmarketing data from the FDA MAUDE from August 2004 to August 2021. Results: Eighty-four MAUDE reports were found in the study period from August 2004 to August 2021. In total, device issues comprised 36.9% of the reports (n=31) and patient adverse events comprised 63.09% of the reports (n=53). Device issues that were reported included, but were not limited to, band placement/deployment failure (8.1%), suture breakage (7.31%), and snare breakage (4.94%). Patient adverse events that were reported included, but were not limited to, bleeding (25.9%), perforation (7.31%), and snare breakage (4.94%). Conclusion: Captivator EMR and Duette EMR have similar patterns of technical failure and clinical adverse events. More MAUDE reports exist for Duette EMR, possibly due to its longer duration of commercial availability.

Assessing the Reproducibility of Research Based on the Food and Drug Administration Manufacturer and User Facility Device Experience Data

“…From 336 articles, 21 that downloaded MAUDE data files were set aside for further analysis 11–31 . Upon manual review, 135 articles with unclear queries 32–164 and 120 with incomplete queries 165–284 were excluded. Ultimately, 60 executable queries were found 5,10,285–342 .…”