MUSTANG?
Report
- Report Number
- 2124215-2025-78676
- Event Type
- Malfunction
- Date Received
- October 31, 2025
- Date of Event
- October 4, 2025
- Report Date
- November 9, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FGE
- UDI-DI
- 08714729793656
- PMA / PMN Number
- K141521
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- 003
Narratives
B5: DESCRIBE EVENT OR PROBLEM: UPDATED TO INCLUDE NEW INFORMATION OBTAINED. D2B: PRO CODE: (PRODUCT CODE): FGE, LIT. G4: PREMARKET / 510(K): K141521, K141597.
D2B: PRO CODE: (PRODUCT CODE): FGE, LIT. G4: PREMARKET / 510(K): K141521, K141597. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE DEVICE STATUS AND ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. AN 8.0 X 80, 75 CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED. NO ADDITIONAL INFORMATION WAS PROVIDED. IT WAS FURTHER REPORTED THAT THE TARGET LESION, WITH 100% STENOSIS, WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ARTERIOVENOUS FISTULA (AVF). DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER 30 SECONDS OF INFLATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AN ALTERNATE DEVICE. THE PATIENTS CONDITION WAS STABLE AND VERY GOOD POST-PROCEDURE.
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. AN 8.0 X 80, 75 CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1385770 | MUSTANG? | STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | FGE | BOSTON SCIENTIFIC CORPORATION | H74939171080870 | 0036888093 | 08714729793656 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |