MUSTANG?
Report
- Report Number
- 2124215-2025-88477
- Event Type
- Malfunction
- Date Received
- December 2, 2025
- Date of Event
- December 1, 2025
- Report Date
- December 22, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FGE
- UDI-DI
- 08714729793854
- PMA / PMN Number
- K141521
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
D2B: PRO CODE: (PRODUCT CODE): FGE, LIT. E1: UPDATED INITIAL REPORTER EMAIL. G4: PREMARKET / 510(K): K141521, K141597.
D2B: PRO CODE: (PRODUCT CODE): FGE, LIT. G4: PREMARKET / 510(K): K141521, K141597.
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 6.0 X 80 MM, 75 CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR LESION DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED WITHIN THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE, AND THE PATIENT REMAINED IN EXCELLENT CONDITION THROUGHOUT.
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 6.0 X 80 MM, 75 CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR LESION DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED WITHIN THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE, AND THE PATIENT REMAINED IN EXCELLENT CONDITION THROUGHOUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2809874 | MUSTANG? | STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | FGE | BOSTON SCIENTIFIC CORPORATION | H74939171060870 | 0037087977 | 08714729793854 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |