MAUDE Adverse Event Report: MEDTRONIC ENGINEERING AND INNOVATION CENTER (MEIC) BRAVO CALIBRATION-FREE REFLUX CAPSULE; ELECTRODE, PH, STOMACH

Model Number 9F277

Patient Problem Foreign Body In Patient (2687)

Event Date 09/20/2023

Event Type  Injury  

Event Description

A physician actuated the bravo capsule deployment when it "crumbled in my hand" per the physician.He stated it felt like the internal spring broke as he attempted to deploy it.The bravo capsule did not adhere to esophagus wall lining as expected and ultimately fell into pt's stomach.Per physician documentation, "bravo placed at 30cm but due to fault with deployment it was dislodged, suction mark seen on esophagus and bravo capsule identified in stomach.".

• Brand Name: BRAVO CALIBRATION-FREE REFLUX CAPSULE
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): MEDTRONIC ENGINEERING AND INNOVATION CENTER (MEIC); minneapolis MN 55432 564
• MDR Report Key: 17818145
• MDR Text Key: 324353806
• Report Number: MW5146148
• 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: 09/21/2023

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: Health Professional
• Device Model Number: 9F277
• Device Catalogue Number: FGS-0636
• Device Lot Number: 60148F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American