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

Model Number 9F2A5

Device Problems Loss of or Failure to Bond (1068); Migration or Expulsion of Device (1395)

Patient Problem Insufficient Information (4580)

Event Date 08/04/2022

Event Type  malfunction  

Event Description

The device (lot# 55942f, id 9f2a5) was correctly placed at 34 cm (ge junction @ 40cm -6cm =34cm).After the surgeon ascertained the correct position for bravo placement, the suction was placed on the device in order for the capsule to detach from the handle.After placement, the md reinserted the egd scope for final inspection and a picture of the capsule was obtained.The surgeon noted that the device failed to attach properly and had migrated up the esophagus.The device was then retrieved and another capsule (lot# 56264f, id# ad87c) was properly placed and adhered to the esophageal tissue at 34cm.Fda safety report id #(b)(4).

• Brand Name: BRAVO CAPSULE
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): MEDTRONIC/GIVEN IMAGING INC.
• MDR Report Key: 15233694
• MDR Text Key: 298115441
• Report Number: MW5111486
• 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: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9F2A5
• Device Catalogue Number: 9F2AF
• Device Lot Number: 55942F
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 122 KG
• Patient Ethnicity: Hispanic
• Patient Race: Black Or African American