MAUDE Adverse Event Report: MEDTRONIC / GIVEN IMAGING, INC. BRAVO CALIBRATION-FREE REFLUX CAPSULE; ELECTRODE, PH, STOMACH

Catalog Number FGS-0635

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Insufficient Information (4580)

Event Date 11/09/2020

Event Type  Injury  

Event Description

Egd was done and appropriate measurement was taken for bravo capsule replacement.Bravo capsule and monitor set up according to directions, with no issues.Bravo device was introduced into the pt to the recorded measurement, with no issues.Suction was turned on and reached 550 mm.The pt had a slight cough that was very minimal.Suction stayed at 550 or above the entire time.We waited 45 sec before deploying, to allow the cough to subside some.Capsule was deployed with no issues and deployment device was removed.F/u egd was done to confirm placement.It was at this time the capsule was found right near the epiglottis and not in the esophagus.The crna was able to use a laryngoscope and a magill forceps to retrieve the capsule.

• Brand Name: BRAVO CALIBRATION-FREE REFLUX CAPSULE
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): MEDTRONIC / GIVEN IMAGING, INC.
• MDR Report Key: 10843782
• MDR Text Key: 216626888
• Report Number: MW5097894
• Device Sequence Number: 1
• Product Code: FFT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2021
• Device Catalogue Number: FGS-0635
• Device Lot Number: 49376F
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 52