MUSTANG?
Report
- Report Number
- 2124215-2025-26182
- Event Type
- Malfunction
- Date Received
- April 24, 2025
- Date of Event
- April 9, 2025
- Report Date
- June 16, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FGE
- UDI-DI
- 08714729793779
- 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. 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. BLOOD WAS NOTED INSIDE THE BALLOON WHICH IS EVIDENCE OF A DEVICE LEAK. A LEAK TEST IDENTIFIED A BALLOON PINHOLE LOCATED APPROXIMATELY 38MM PROXIMAL OF THE DISTAL MARKERBAND. THE RATED BURST PRESSURE FOR THIS DEVICE AS PER SPECIFICATION 90519237 IS 20 ATMOSPHERES. A VISUAL AND TACTILE EXAMINATION FOUND NO KINKS OR DAMAGE TO THE SHAFT OF THE DEVICE. A VISUAL AND TACTILE EXAMINATION FOUND NO DAMAGE TO THE TIP OF THE DEVICE. A VISUAL EXAMINATION OBSERVED NO ISSUES WITH THE MARKERBANDS OF THE DEVICE. BOTH MARKERBANDS WERE UNDAMAGED IN THE CORRECT POSITION ON THE DEVICE.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS AN AREA OF IN-STENT RESTENOSIS (ISR) LOCATED IN THE SEVERELY CALCIFIED BRACHIAL VEIN. A 7.0 X 100, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING FIRST INFLATION AT 20 ATMOSPHERES FOR 20 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED TARGET LESION WAS ALSO LOCATED IN A SEVERE TORTUOUS VEIN.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS AN AREA OF IN-STENT RESTENOSIS (ISR) LOCATED IN THE SEVERELY CALCIFIED BRACHIAL VEIN. A 7.0 X 100, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING FIRST INFLATION AT 20 ATMOSPHERES FOR 20 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS AN AREA OF IN-STENT RESTENOSIS (ISR) LOCATED IN THE SEVERELY CALCIFIED BRACHIAL VEIN. A 7.0 X 100, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING FIRST INFLATION AT 20 ATMOSPHERES FOR 20 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED TARGET LESION WAS ALSO LOCATED IN A SEVERE TORTUOUS VEIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1276181 | MUSTANG? | STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | FGE | BOSTON SCIENTIFIC CORPORATION | H74939171071070 | 0035568407 | 08714729793779 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |