MUSTANG?
Report
- Report Number
- 2124215-2025-89623
- Event Type
- Malfunction
- Date Received
- December 8, 2025
- Date of Event
- November 20, 2025
- Report Date
- March 9, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FGE
- UDI-DI
- 08714729794264
- PMA / PMN Number
- K141521
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
B5 - DESCRIBE EVENT OR PROBLEM UPDATED. D2B - PRO CODE (PRODUCT CODE): FGE, LIT. G4 - PREMARKET / 510(K): FGE, LIT.
D2B - PRO CODE (PRODUCT CODE): FGE, LIT. G4 - PREMARKET / 510(K): FGE, LIT.
D2B - PRO CODE (PRODUCT CODE): FGE, LIT. G4 - PREMARKET / 510(K): K141521, K141597. WITH THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES: DEVICE HISTORY RECORD (DHR) REVIEW, IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. DEVICE TECHNICAL ANALYSIS THE MUSTANG DEVICE WAS RETURNED FOR EVALUATION. A VISUAL EXAMINATION IDENTIFIED THAT THE BALLOON WAS NOT FOLDED, WHICH INDICATES THAT THE DEVICE WAS SUBJECTED TO POSITIVE PRESSURE. A LEAK TEST WAS CARRIED OUT, AND THE BALLOON WAS INFLATED TO ITS RATED BURST PRESSURE FOR 30 SECONDS USING DEIONIZED WATER AND DIGITAL TIMER, WITHOUT ISSUE. A VACUUM WAS THEN APPLIED. THE INFLATION DEVICE WAS VERIFIED AT 20 ATMOSPHERES, BEFORE AND AFTER USE WITH CALIBRATED PRESSURE GAUGE. THIS INFLATION TO RATE OF BURST PRESSURE WAS REPEATED THREE TIMES WITH NO LEAKS OR DROP IN PRESSURE NOTED. NO ISSUES WERE IDENTIFIED WITH BALLOON INFLATION OR THE BALLOON MATERIAL. AS PER SPECIFICATION, THE RATED BURST PRESSURE FOR THIS DEVICE IS 20 ATMOSPHERES. NO ISSUES WERE NOTED WITH THE TIP OF THE DEVICE. A VISUAL EXAMINATION FOUND NO ISSUE WITH THE MARKERBANDS. A VISUAL AND TACTILE EXAMINATION FOUND A SHAFT KINK/ STRETCHED APPROXIMATELY 110MM PROXIMAL FROM THE DISTAL TIP. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. LABELING REVIEW, REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THAT THE CONTENT WAS SUFFICIENT AND DID NOT CONTRIBUTE TO THE REPORTED EVENT; THEREFORE, NO UPDATES ARE REQUIRED TO THE DOCUMENT AT THIS TIME. RISK REVIEW, A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF BALLOON- MATERIAL RUPTURE WAS DEFINED IN THE RISK DOCUMENTATION AND IS DOCUMENTED ACCORDINGLY IN THE PRR. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. INVESTIGATION CONCLUSION, BOSTON SCIENTIFIC CONCLUDES THE MOST PROBABLE ROOT CAUSE AS NO PROBLEM DETECTED, BASED ON THE RESULTS OF THE PRODUCT ANALYSIS, AND AS THE INVESTIGATOR INFLATED THE BALLOON TO ITS RATED BURST PRESSURE OF 20 ATMOSPHERES, WITH NO LEAKS OR ISSUES NOTED, SO THE COMPLAINT INCIDENT CANNOT BE CONFIRMED. THE UNREPORTED KINK NOTED DURING DEVICE ANALYSIS OCCURRED MOST LIKELY AS A RESULT OF INTERACTION BETWEEN THE USER AND THE DEVICE (UNINTENDED), AT WHICH STAGE OF THE PROCEDURE IT OCCURRED (DURING PROCEDURE/HANDLING POST PROCEDURE) CANNOT BE ESTABLISHED.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 7.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ARTERIOVENOUS FISTULA (AVF). THE BALLOON RUPTURED FOR 1 MINUTE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 7.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 7.0 X 80, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ARTERIOVENOUS FISTULA (AVF). THE BALLOON RUPTURED FOR 1 MINUTE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 156508 | MUSTANG? | STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | FGE | BOSTON SCIENTIFIC CORPORATION | H74939171070870 | 0037226744 | 08714729794264 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |