MUSTANG?
Report
- Report Number
- 2124215-2025-59742
- Event Type
- Malfunction
- Date Received
- August 26, 2025
- Date of Event
- August 11, 2025
- Report Date
- December 1, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FGE
- UDI-DI
- 08714729794745
- 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 - 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 DEVICE WAS RETURNED FOR EVALUATION. A VISUAL EXAMINATION IDENTIFIED THAT THE BALLOON WAS NOT FOLDED WHICH INDICATES THAT THE BALLOON WAS SUBJECTED TO POSITIVE PRESSURE. THE RATED BURST PRESSURE FOR THIS DEVICE IS 14 ATMOSPHERES AS PER MUSTANG SPECIFICATION. THE RETURNED DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT. POSITIVE PRESSURE WAS APPLIED WHEN DI WATER WAS OBSERVED TO BE LEAKING FROM A BALLOON PINHOLE LOCATED APPROXIMATELY 40MM DISTAL FROM THE PROXIMAL MARKERBAND. A VISUAL AND TACTILE EXAMINATION IDENTIFIED NO KINKS OR DAMAGE TO THE SHAFT, TIP, AND MARKERBANDS. THIS CONCLUDES THE PRODUCT ANALYSIS.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS, AND MODERATELY CALCIFIED CENTRAL VESSEL. A 12.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED OCCURRED JUST BEFORE REACHING THE PRESSURE. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO PATIENT INJURY AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS, AND MODERATELY CALCIFIED CENTRAL VESSEL. A 12.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED OCCURRED JUST BEFORE REACHING THE PRESSURE. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO PATIENT INJURY AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS, AND MODERATELY CALCIFIED CENTRAL VESSEL. A 12.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED OCCURRED JUST BEFORE REACHING THE PRESSURE. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO PATIENT INJURY AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1507005 | MUSTANG? | STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | FGE | BOSTON SCIENTIFIC CORPORATION | H74939171120870 | 0036310546 | 08714729794745 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Unknown |