S1329 Adverse Events Associated With Esophageal Balloon Tamponade Devices: A 15-Year Retrospective Analysis of the FDA MAUDE Database

Introduction: Esophageal balloon tamponade devices are critical interventions for controlling life-threatening variceal bleeding. Despite their therapeutic importance, limited data exists regarding device-related adverse events in post-marketing surveillance. This study analyzes the FDA MAUDE database to characterize adverse events associated with esophageal balloon tamponade devices. Methods: A retrospective analysis of MAUDE database reports from 2010-2025 involving esophageal balloon tamponade devices was conducted. Reports were manually reviewed and categorized into device-related and patient-related adverse events. Duplicate reports were excluded. Event frequencies and percentages were calculated. Results: A total of 40 valid reports were identified involving esophageal balloon tamponade devices. There were 54 device-related events and 52 patient-related events identified. Device-related events were predominantly material integrity issues (18.5%), inflation/deflation problems (16.7%), and deployment/removal difficulties (14.8%). Separation/detachment issues and burst/rupture events each occurred in 6 events (11.1%). Patient-related events included problems with no impact or consequence (73.1%) and unavailable code (11.5%). Serious adverse events included death (3.8%), exsanguination (1.9%), and hemorrhage/bleeding (1.9%). Death was noted in 2 reports with an overall mortality rate of 5.0%. Conclusion: This analysis reveals important safety considerations for esophageal balloon tamponade devices, with device malfunction being predominant (85.0%). Material integrity issues (18.5%) and inflation/deflation problems (16.7%) were the most frequent device problems, highlighting concerns about structural durability and pressure management. Most patient-related events (73.1%) resulted in no clinical impact. However, serious adverse events including death (3.8%) emphasize the critical nature of proper device function in emergency scenarios. These findings highlight the need for improved device reliability and practitioner training.