Northwell Health, Lenox Hill Hospital New York, NY
Introduction: The Bravo pH capsule monitoring system is a widely utilized diagnostic tool to identify and treat patients with gastroesophageal reflux disorder. While the Bravo pH capsule is minimally invasive, the associated procedural complications are not well described. We aim to investigate post Food and Drug Administration (FDA) approval outcomes associated with the Bravo pH capsule.
Methods: We analyzed post-marketing surveillance data on the Bravo pH capsule from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from January 2016 to December 2021 to report device-related injuries and modes of failure. This database is an open access platform that receives device reports from mandatory sources, including manufacturers and facilities, as well as, voluntary sources such as healthcare professionals and patients. These reports allow the FDA to monitor device performance and device-related safety concerns.
Results: During the study period, approximately 4210 reported cases with 4655 device issues and 759 patient complications were examined. The most reported device issues were due to loss of or failure to bond (n= 2190, 47.1%), followed by malposition (n= 1074, 23.1%), detachment of device (n= 325, 7.0%), communication or transmission problems (n= 270, 5.8%), and entrapment of device (n= 104, 2.2%). The most reported patient complications were airway obstruction (n= 156, 20.6%), foreign body retention (n= 107, 14.1%), unintended radiation exposure (n= 69, 9.1%), aspiration/inhalation (n= 59, 7.8%), and pain (n= 53, 7.0%). A number of cases reported unspecified complications with insufficient information (n= 50, 6.6%).
Discussion: The Bravo pH capsule is routinely utilized by Gastroenterologists for ambulatory pH monitoring. Our analysis of the FDA MAUDE database revealed a predominance of reported device complications related to capsule adherence and placement difficulties. In our study, airway obstruction represented the most commonly reported patient adverse event. This database has notable limitations, including limited information on patient comorbidities, detailed endoscopy reports, and an absence of a total volume of procedures performed in the United States. Furthermore, reporting can be inconsistent and underreported. This study provides insight into the most commonly reported complications of the Bravo pH capsule that will help inform the risk/benefit conversation with patients and may lead to a more detailed approach on how to mitigate and manage complications.
