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Patient adverse events and technical failures with the bravo capsule pH system: insights from the MAUDE database
Daryl Ramai1, Peter Bhandari2, Anjali Kewalramani3
1Division of Gastroenterology and Hepatology, University of Utah, Salt Lake City, UT, USA.
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.
Insights
The BRAVO pH capsule, used for GERD monitoring, carries risks including aspiration, bleeding, and perforation. Device failures often involve adhesion issues or activation problems, highlighting potential complications.
Area of Science:
- Gastroenterology
- Medical Devices
- Patient Safety
Background:
- The BRAVO pH monitoring system aids GERD patients with persistent or atypical symptoms.
- Investigating complications associated with the BRAVO pH capsule is crucial for patient care.
Purpose of the Study:
- To determine the incidence and types of complications linked to the BRAVO pH capsule.
- To analyze adverse events reported in post-marketing surveillance data.
Main Methods:
- Utilized FDA Manufacturer and User Facility Device Experience (MAUDE) database.
- Analyzed post-marketing surveillance data from April 2016 to February 2021.
- Identified and categorized device failures and patient-related adverse events.
Main Results:
- Over 1,651 reports identified, with 2,391 device failures and 254 patient adverse events.
- Common complications included aspiration (153), pain (79), injury (63), and bleeding (19).
- Device failures frequently involved adhesion (1,269), activation/positioning (972), and detachment (284).
Conclusions:
- BRAVO capsule placement poses risks of aspiration, hemorrhage, perforation, injury, and retention.
- Findings underscore the importance of monitoring for these adverse events.
- Data highlights the need for improved device adhesion and function.
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