MAUDE Adverse Event Report: MEDTRONIC, INC. BRAVO REFLUX CAPSULE; ELECTRODE PH STOMACH

Catalog Number FGS-0312

Device Problem Activation Problem (4042)

Patient Problem Tissue Damage (2104)

Event Date 11/09/2019

Event Type  Injury  

Event Description

Bravo capsule failed to deploy from the bravo catheter after it was clipped, causing tear in esophagus.

• Brand Name: BRAVO REFLUX CAPSULE
• Type of Device: ELECTRODE PH STOMACH
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 9362967
• MDR Text Key: 167788194
• Report Number: MW5091250
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/11/2020
• Device Catalogue Number: FGS-0312
• Device Lot Number: 46939Q
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/21/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 154