S298 Trapezoid RX Wire Guided Retrieval Basket Device Related Complications: Food and Drug Administration Database Analysis Involving Manufacturer and User Facility Device Experience

Introduction: According to the American Society for Gastrointestinal Endoscopy, approximately 450,000-500,000 endoscopic retrograde cholangiopancreatography (ERCP) procedures are performed annually in the United States for diagnostic and therapeutic biliary and pancreatic interventions. Although pancreatitis and bleeding are the most common procedural complications, device-related issues account for a no 5%-10% of adverse events. Our study analyzed post-marketing surveillance data from the Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database to evaluate complications associated with widely used Trapezoid RX Wire Guided Retrieval Basket during ERCP. Methods: A systematic search of Food and Drug Administration’s MAUDE database for Trapezoid reports from 2014 to 2024 was conducted. After excluding duplicates and incomplete entries, 500 adverse events were analyzed. Data were categorized by event type, device problem, and patient complications, with stratification by manufacturer-confirmed errors. Results: We reviewed 500 MAUDE database reports related to the Trapezoid device and classified adverse events into two categories: device failures and patient complications. The most common device-related issues were breakage (52.5%), material deformation (23.2%), and malfunction (15.6%). Patient-related complications were less frequent, including foreign body retention (1.6%), surgical retrieval of retained devices (1.2%), hemorrhage (0.8%), and a single case of fatal hepatic pseudoaneurysm (0.2%). Conclusion: The Trapezoid is specifically engineered to fragment and extract biliary stones during the ERCP, combining flexible navigation with rigid retrieval capabilities enhances complex biliary access, cannulation and needle-knife-free precut sphincterotomies. Analysis of MAUDE database reports highlights critical safety concerns, including device fractures, material deformations, and functional failures that demand immediate quality control measures. Additionally, the recurring issue of retained foreign bodies often necessitating repeat interventions or even exploratory surgery highlights the urgent need for enhanced procedural oversight. Moving forward, optimizing the trapezoid device's clinical utility will require dual focus: reinforcing device resilience to prevent mechanical failures and implementing standard safety guidelines to minimize complications, thereby elevating both patient safety and procedural efficacy in ERCP interventions.