FDA Adverse Event
Malfunction
Summary report: N
MUSTANG?
MDR report key: 24690910
·
Received March 25, 2026
Report
- Report Number
- 2124215-2026-16426
- Event Type
- Malfunction
- Date Received
- March 25, 2026
- Date of Event
- February 25, 2026
- Report Date
- May 14, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FGE
- UDI-DI
- 08714729793991
- PMA / PMN Number
- K103751
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
D2B - PRO CODE (PRODUCT CODE): FGE, LIT. G4 - PREMARKET/510(K): K103751, K110122.
Description of Event or Problem · 0
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 3.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE BALLOON WAS RUPTURED AND LEAK WAS NOTED, THEREFORE IT COULD NOT BE INFLATED. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1768 | MUSTANG? | STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | FGE | BOSTON SCIENTIFIC CORPORATION | H74939171030270 | 0035827821 | 08714729793991 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |