MAUDE Adverse Event Report: MEDTRONIC / GIVEN IMAGING INC. BRAVO PH; BRAVO PH DEVICE DELIVERY SYSTEM, ELECTRODE, PH, STOMACH

Lot Number 48088F

Device Problems Failure to Advance (2524); Material Twisted/Bent (2981)

Patient Problem Laceration(s) (1946)

Event Date 05/07/2020

Event Type  Injury  

Event Description

A medtronic bravo device delivery system, used during an egd was found to be bent after multiple attempts were made to introduce it into the esophagus.A 1 cm laceration was later identified on the patient's rear soft pallet.This injury did not require additional invasive or surgical intervention.Fda safety report id# (b)(4).

• Brand Name: BRAVO PH
• Type of Device: BRAVO PH DEVICE DELIVERY SYSTEM, ELECTRODE, PH, STOMACH
• Manufacturer (Section D): MEDTRONIC / GIVEN IMAGING INC.
• MDR Report Key: 10086751
• MDR Text Key: 192172732
• Report Number: MW5094660
• 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: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 48088F
• Is the Reporter a Health Professional?: Yes
• 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): Other
• Patient Age: 33 YR
• Patient Weight: 122