MUSTANG?
Report
- Report Number
- 2124215-2025-93054
- Event Type
- Malfunction
- Date Received
- December 25, 2025
- Date of Event
- December 9, 2025
- Report Date
- March 16, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FGE
- UDI-DI
- 08714729794509
- PMA / PMN Number
- K103751
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B5. DESCRIBE EVENT OR PROBLEM: ADDED INFORMATION, BASED ON ADDITIONAL INFORMATION. D2B - PRO CODE (PRODUCT CODE): FGE, LIT. E1 - INITIAL REPORTER PHONE: (B)(6). E1 - INITIAL REPORTER EMAIL: ADDED. G4 - PREMARKET / 510(K) #: K103751, K110122, K141521.
D2B. PRO CODE (PRODUCT CODE): FGE, LIT. E1. INITIAL REPORTER PHONE: (B)(6). G4. PREMARKET / 510(K) #: K103751, K110122, K141521.
D2B - PRO CODE (PRODUCT CODE): FGE, LIT. E1 - INITIAL REPORTER PHONE: (B)(6). G4 - PREMARKET / 510(K) #: K103751, K110122, K141521. 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 BALLOON WAS SUBJECTED TO POSITIVE PRESSURE. A LONGITUDINAL TEAR WAS IDENTIFIED IN THE BALLOON MATERIAL. THE TEAR MEASURED APPROXIMATELY 35MM IN LENGTH AND WAS LOCATED IN THE MID REGION OF THE BALLOON. 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. 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 ADVERSE EVENT RELATED TO PATIENT CONDITION, BASED ON THE RESULTS OF PRODUCT ANALYSIS, THERE BEING NO REPORTED DEVICE INTERACTION/ DAMAGE OR ISSUE UNTIL INFLATION WAS ATTEMPTED AT THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED LESION SITE. THIS WOULD SUGGEST THAT PATIENT ANATOMY/LESION CHARACTERISTICS MOST PROBABLY CONTRIBUTED TO THE BALLOON TEAR.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA (AVF). A 6.0 X 200MM,75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED WHILE BEING INFLATED INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS SEVERELY TORTUOUS AND MODERATELY CALCIFIED. THE BALLOON WAS RUPTURED DURING FIRST INFLATION FOR 30 SECONDS.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA (AVF). A 6.0 X 200, 75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED WHILE BEING INFLATED INSIDE THE PATIENT BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA (AVF). A 6.0 X 200MM,75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED WHILE BEING INFLATED INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS SEVERELY TORTUOUS AND MODERATELY CALCIFIED. THE BALLOON WAS RUPTURED DURING FIRST INFLATION FOR 30 SECONDS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 157575 | MUSTANG? | STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | FGE | BOSTON SCIENTIFIC CORPORATION | H74939171062070 | 0037034923 | 08714729794509 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Female |