MUSTANG
Report
- Report Number
- 2124215-2025-02360
- Event Type
- Malfunction
- Date Received
- January 21, 2025
- Date of Event
- January 6, 2025
- Report Date
- March 6, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FGE
- UDI-DI
- 08714729794868
- PMA / PMN Number
- K141521
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
D2B: PRO CODE - LIT. G4: PMA/510(K) # FIELD ON 3500A FORM - K141597.
D2B: PRO CODE - LIT. G4: PMA/510(K) # FIELD ON 3500A FORM - K141597.
IT VWAS REPORTED BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE SUBCLAVIAN VESSEL. A 9.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, A BURST OCCURRED AS THE PRESSURE WAS GRADUALLY INCREASED TO THE BURST PRESSURE LEVEL. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.
IT WAS REPORTED BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE SUBCLAVIAN VESSEL. A 9.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, A BURST OCCURRED AS THE PRESSURE WAS GRADUALLY INCREASED TO THE BURST PRESSURE LEVEL. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 664117 | MUSTANG | STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | FGE | BOSTON SCIENTIFIC CORPORATION | H74939171090870 | 0033371509 | 08714729794868 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Female |