Patient adverse events and technical failures with the bravo capsule pH system: insights from the MAUDE database.

Abstract

Background: The BRAVO pH monitor system can benefit patients with ongoing GERD symptoms despite treatment and/or atypical symptoms. We aim to investigate the number and type of complications associated with the BRAVO pH capsule.

Methods: From April 2016 through February 2021, we analyzed post-marketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database.

Results: During the study period, approximately 1,651 reports were identified with 2391 cases associated with a device failure, and 254 reporting a patient-related adverse event. Most device complications were due to aspiration n = 153), followed by reported pain (n = 79), injury (unspecified) (n = 63), and additional radiologic imaging (n = 44). Laceration and bleeding accounted for 29 and 19 cases. Furthermore, three patients suffered perforation. Most device failures were due to loss or failure of the Bravo capsule to bond or adhere to the esophageal mucosa as planned (n = 1269), followed by an activation or positioning failure (n = 972), premature detachment of device (n = 284), and failure of the device to record or transmit data (n = 158).

Conclusions: Findings from the MAUDE database highlight the risk of aspiration, hemorrhage/bleeding, perforation, injury, and retention as potential complications of BRAVO capsule placement.