MUSTANG
Report
- Report Number
- 2124215-2025-07853
- Event Type
- Malfunction
- Date Received
- February 12, 2025
- Date of Event
- January 20, 2025
- Report Date
- March 11, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FGE
- UDI-DI
- 08714729793625
- PMA / PMN Number
- K141521
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
D2B - ADDITIONAL PRO CODE (PRODUCT CODE): LIT G4 - ADDITIONAL PREMARKET / 510(K): K141597.
D2B - PRO CODE (PRODUCT CODE): FGE, LIT. G4 - PREMARKET / 510(K): K141521, K141597.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.0 X 100, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION, THE BALLOON RUPTURED WITHIN THE LESION. NO COMPLICATIONS REPORTED, AND THE PATIENT WAS IN VERY GOOD CONDITION.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.0 X 100 MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION, THE BALLOON RUPTURED WITHIN THE LESION. NO COMPLICATIONS REPORTED, AND THE PATIENT WAS IN VERY GOOD CONDITION. IT WAS FURTHER REPORTED THAT THE 100% STENOSED TARGET LESION WAS LOCATED IN THE RADIOCEPHALIC FISTULA. THE DEVICE WAS SELECTED FOR ARTERIOVENOUS FISTULA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (AVF PTA). THE DEVICE WAS REMOVED WITHOUT ANY ISSUES, AND THE PROCEDURE WAS COMPLETED ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 904491 | MUSTANG | STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | FGE | BOSTON SCIENTIFIC CORPORATION | H74939171061070 | 0034710177 | 08714729793625 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |