MUSTANG?
Report
- Report Number
- 2124215-2025-67211
- Event Type
- Malfunction
- Date Received
- September 24, 2025
- Date of Event
- September 2, 2025
- Report Date
- November 21, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FGE
- UDI-DI
- 08714729793489
- PMA / PMN Number
- K141521
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
D2B: PRO CODE (PRODUCT CODE) - FGE, LIT. E1: INITIAL REPORTER ADDRESS 1 - (B)(6). G4: PREMARKET / 510(K) # - K141521, K14159.
D2B: PRO CODE (PRODUCT CODE) - FGE, LIT. E1: INITIAL REPORTER ADDRESS: (B)(6). G4: PREMARKET / 510(K) # - K141521, K14159. DEVICE EVALUATED BY MFR: THE MUSTANG DEVICE WAS RETURNED TO OUR POST MARKET QUALITY ASSURANCE LABORATORY. A VISUAL EXAMINATION IDENTIFIED THAT THE BALLOON WAS NOT FOLDED WHICH INDICATES THAT THE BALLOON WAS SUBJECTED TO POSITIVE PRESSURE. A LONGITUDINAL TEAR WAS IDENTIFIED IN THE BALLOON MATERIAL. THE TEAR MEASURED APPROXIMATELY 50MM IN LENGTH AND EXTENDED FROM A POSITION 8MM PROXIMAL OF THE PROXIMAL MARKERBAND TO 4MM DISTAL OF THE DISTAL 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. BOTH MARKERBANDS WERE UNDAMAGED AND PRESENT ON THE SHAFT OF THE DEVICE. THIS CONCLUDES THE PRODUCT ANALYSIS.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUBCLAVIAN VEIN. A 9.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 18 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. 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. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUBCLAVIAN VEIN. A 9.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 18 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. 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 |
|---|---|---|---|---|---|---|---|
| 2384205 | MUSTANG? | STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | FGE | BOSTON SCIENTIFIC CORPORATION | H74939171090470 | 0035794638 | 08714729793489 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |