MAUDE Adverse Event Report: MEDTRONIC INC/ COVIDIEN LLC / GIVEN IMAGING INC BRAVO REFLUX CAPSULE; ELECTRODE, PH, STOMACH

Lot Number 53048F

Device Problems Break (1069); Device Dislodged or Dislocated (2923); Activation Failure (3270)

Patient Problem Laceration(s) of Esophagus (2398)

Event Date 06/15/2021

Event Type  Injury  

Event Description

The bravo was inserted and held with suction for 30 seconds when the dr went to deploy it did not deploy.He then broke the handle to do an emergency release but the capsule still did not deploy.He used the gastroscope to gain visualization and used a snare to dislodge the chip.Once the chip was dislodged from the mucosa, he went back down and placed clips because as a result there was a superficial tear.From discussing with team members, proper technique was used with the deployment of the bravo device yet, it failed to deploy properly.Clips were applied to the esophagus due to this esophageal injury.Fda safety report id # (b)(4).

• Brand Name: BRAVO REFLUX CAPSULE
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): MEDTRONIC INC/ COVIDIEN LLC / GIVEN IMAGING INC
• MDR Report Key: 12210602
• MDR Text Key: 263110890
• Report Number: MW5102683
• Device Sequence Number: 1
• Product Code: FFT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 53048F
• Was Device Available for Evaluation?: 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): Required Intervention
• Patient Age: 70 YR