Clinical Adverse Events and Device Failures for the Barrx™ Radiofrequency Ablation Catheter System: a MAUDE Database Analysis

Background: The Barrx™ radiofrequency ablation (RFA) catheter system comes in several different variations and sizes and is widely used for the eradication of Barrett's esophagus (BE). The Barrx™ 360 and 360 Express system is used to perform circumferential RFA, while the Barrx™ focal catheter system is used for secondary focal RFA or primary treatment of short-segment BE. We aimed to investigate the number and type of complications and device failures associated with the Barrx™ RFA catheter system.

Method: We analyzed post-marketing surveillance data from the Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database from August 2011 to August 2021.

Results: During the study period, 148 unique reports detailing 78 device issues and 87 patient-related adverse events were identified. The most reported adverse events for patients were stenosis secondary to treatment (n=15, 17.24%), mucosal laceration of the esophagus (n=13, 14.94%), chest pain (n=10, 11.49%), and odynophagia/dysphagia (n=7, 8.05%). The most common device complication was failure of the device to deploy when activated (n=10, 13.82%). Other device malfunctions included material deformation/distortion (n=7, 8.97%), catheter breakage (n=6, 7.69%), connection problems between the generator cable and RFA device (n=6, 7.69%), and failure of the balloon to properly inflate (n=5, 6.41%).

Conclusion: Findings from the MAUDE database highlight patient and device complications that endoscopists should be aware of prior to RFA of BE with the Barrx™ RFA catheter system.