MUSTANG?
Report
- Report Number
- 2124215-2025-47295
- Event Type
- Malfunction
- Date Received
- July 15, 2025
- Date of Event
- June 19, 2025
- Report Date
- September 25, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LIT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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.
D2B: PRO CODE (PRODUCT CODE): FGE, LIT. G4: PREMARKET / 510(K) #: K141521, K141597. DEVICE EVALUATED BY MFR: THE MUSTANG WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION IDENTIFIED THAT THE BALLOON WAS NOT FOLDED WHICH INDICATES THAT THE BALLOON WAS SUBJECTED TO POSITIVE PRESSURE. A PARTIAL BALLOON CIRCUMFERENTIAL TEAR WAS IDENTIFIED LOCATED APPROXIMATELY 17MM PROXIMAL OF THE DISTAL BALLOON MARKERBAND. A VISUAL EXAMINATION OBSERVED NO DAMAGE TO THE TIP OF THE DEVICE. A VISUAL AND TACTILE EXAMINATION FOUND NO KINKS OR DAMAGE TO THE SHAFT OF THE DEVICE.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. IT WAS NOTED THAT THE BALLOON WAS RUPTURE AT NOMINAL PRESSURE (10 ATMOSPHERES). THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. IT WAS NOTED THAT THE BALLOON WAS RUPTURE AT NOMINAL PRESSURE (10 ATMOSPHERES). THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION FOR 10 SECONDS. 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. A 6.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. IT WAS NOTED THAT THE BALLOON WAS RUPTURE AT NOMINAL PRESSURE (10 ATMOSPHERES). THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION FOR 10 SECONDS. 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 |
|---|---|---|---|---|---|---|---|
| 1534640 | MUSTANG? | STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | LIT | BOSTON SCIENTIFIC CORPORATION | H74939171060670 | 0029848443 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |