MalfunctionFFT
BRAVO DELIVERY DEVICE
Received Jun 29, 2026 · Event occurred Jun 11, 2026
Report MW5189936 · MDR key 25650706
Device
Product problems
- Separation Failure
Patient
79 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
BRAVO DID NOT DETACH FROM THE DELIVERY DEVICE. TRIED ANOTHER ONE AND SAME RESULT. TRIED ANOTHER FROM A DIFFERENT LOT AND HAD NO ISSUES. TWO REMAINING BRAVO CAPSULES OF SAME LOT PULLED FROM SUPPLY. FAILURES REPORTED TO MEDTRONIC. PT: 4582. DEVICE: 2547. REF: MW5189937. REPORTS ON BRAVO DELIVERY DEVICE #1.