MUSTANG?
Report
- Report Number
- 2124215-2025-62459
- Event Type
- Malfunction
- Date Received
- September 5, 2025
- Date of Event
- August 12, 2025
- Report Date
- November 27, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FGE
- UDI-DI
- 08714729793779
- PMA / PMN Number
- K141521
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
D2B - PRO CODE (PRODUCT CODE): FGE, LIT. G4 - PREMARKET / 510(K) #: K141521, K141597.
UPDATED E1: INITIAL REPORTER FIRST NAME. UPDATED E1: INITIAL REPORTER EMAIL. D2B - PRO CODE (PRODUCT CODE): FGE, LIT. G4 - PREMARKET / 510(K) #: K141521, K141597.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED COMMON ILIAC ARTERY. A 7.0 X 100, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE THIRD INFLATION AT 12 ATMOSPHERES FOR 1 MINUTE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED COMMON ILIAC ARTERY. A 7.0 X 100, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE THIRD INFLATION AT 12 ATMOSPHERES FOR 1 MINUTE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1975676 | MUSTANG? | STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | FGE | BOSTON SCIENTIFIC CORPORATION | H74939171071070 | 0036458211 | 08714729793779 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |