MUSTANG?
Report
- Report Number
- 2124215-2026-06778
- Event Type
- Malfunction
- Date Received
- February 5, 2026
- Date of Event
- January 19, 2026
- Report Date
- February 24, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FGE
- UDI-DI
- 08714729793861
- 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. G4: PREMARKET / 510(K): K141521, K141597. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE THE PRODUCT STATUS AND ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.
B5 - DESCRIBE EVENT OR PROBLEM: UPDATED TO INCLUDE NEW INFORMATION OBTAINED. D2B: PRO CODE: (PRODUCT CODE): FGE, LIT. G4: PREMARKET / 510(K): K141521, K141597.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 7.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED. NO ADDITIONAL INFORMATION WAS PROVIDED.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 7.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED. NO ADDITIONAL INFORMATION WAS PROVIDED. IT WAS FURTHER REPORTED THAT THE 100% STENOSED TARGET LESION WAS LOCATED WITHIN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ARTERIOVENOUS FISTULA. DURING THE PROCEDURE, THE BALLOON WAS INFLATED TWICE. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING A NON-BOSTON SCIENTIFIC DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 336385 | MUSTANG? | STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | FGE | BOSTON SCIENTIFIC CORPORATION | H74939171070670 | 0037437192 | 08714729793861 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |