MUSTANG?
Report
- Report Number
- 2124215-2025-61135
- Event Type
- Malfunction
- Date Received
- September 2, 2025
- Date of Event
- August 12, 2025
- Report Date
- November 27, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FGE
- UDI-DI
- 08714729793762
- PMA / PMN Number
- K141521
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
E1 - INITIAL REPORTER EMAIL: ADDED. D2B- PRO CODE (PRODUCT CODE): FGE, LIT. E1 - INITIAL REPORTER PHONE: (B)(6). G4 - PREMARKET / 510(K): K141521, K141597. DEVICE EVALUATED BY MFR: THE 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. A LONGITUDINAL TEAR WAS IDENTIFIED IN THE BALLOON MATERIAL. THE TEAR MEASURED APPROXIMATELY 11MM IN LENGTH AND EXTENDED FROM A POSITION 6MM PROXIMAL OF THE PROXIMAL MARKERBAND TO 4MM DISTAL OF THE PROXIMAL 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. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS.
D2B- PRO CODE (PRODUCT CODE): FGE, LIT. (B)(6). H4 - DEVICE MANUFACTURE DATE UPDATED. G4 - PREMARKET / 510(K): K141521, K141597.
D2B- PRO CODE (PRODUCT CODE): FGE, LIT. E1 - INITIAL REPORTER PHONE: +011(820)50713348965. G4 - PREMARKET / 510(K): K141521, K141597. DEVICE EVALUATED BY MFR: THE 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. A LONGITUDINAL TEAR WAS IDENTIFIED IN THE BALLOON MATERIAL. THE TEAR MEASURED APPROXIMATELY 11MM IN LENGTH AND EXTENDED FROM A POSITION 6MM PROXIMAL OF THE PROXIMAL MARKERBAND TO 4MM DISTAL OF THE PROXIMAL 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. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS.
D2B- PRO CODE (PRODUCT CODE): FGE, LIT. E1 - INITIAL REPORTER PHONE: (B)(6). G4 - PREMARKET / 510(K): K141521, K141597.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 60-70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED BRACHIOCEPHALIC FISTULA ANASTOMOSIS. A 6.0 X 60, 75CM MUSTANG BALLOON WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. DURING INFLATION, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INJURY AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 60-70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED BRACHIOCEPHALIC FISTULA ANASTOMOSIS. A 6.0 X 60, 75CM MUSTANG BALLOON WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. DURING INFLATION, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INJURY AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 60-70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED BRACHIOCEPHALIC FISTULA ANASTOMOSIS. A 6.0 X 60, 75CM MUSTANG BALLOON WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. DURING INFLATION, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INJURY AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 60-70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED BRACHIOCEPHALIC FISTULA ANASTOMOSIS. A 6.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. DURING INFLATION, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF 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 |
|---|---|---|---|---|---|---|---|
| 2086554 | MUSTANG? | STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | FGE | BOSTON SCIENTIFIC CORPORATION | H74939171060670 | 0035568349 | 08714729793762 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Male |