BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUSTANG?

    MDR report key: 24520550 · Received March 5, 2026

    Report

    Report Number
    2124215-2026-10979
    Event Type
    Injury
    Date Received
    March 5, 2026
    Date of Event
    January 30, 2026
    Report Date
    March 26, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729795254
    PMA / PMN Number
    K141521
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: PRO CODE: (PRODUCT CODE): FGE, LIT. (B)(6). G4: PREMARKET / 510(K): K141521, K141597. INVESTIGATION RESULTS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD: IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. 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 PERFORMED FOR THE MUSTANG BALLOON DEVICE CONFIRMED THAT THE EVENT OF BALLOON MATERIAL RUPTURE AND BALLOON DAMAGED/DEFECTIVE ARE KNOWN EVENTS DEFINED IN THE PRODUCTS RISK MANAGEMENT DOCUMENTATION. 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 THERE BEING NO REPORTED DEVICE INTERACTION/ DAMAGE OR ISSUE UNTIL THE BALLOON WAS INFLATED IN THE THROMBOSED VESSEL. THIS WOULD SUGGEST THAT PATIENT ANATOMY MOST PROBABLY CONTRIBUTED TO THE BALLOON RUPTURE/DAMAGE. IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE PAIN AND NUMBNESS.

    Additional Manufacturer Narrative · 0

    D2B: PRO CODE: (PRODUCT CODE): FGE, LIT. E1 - INITIAL REPORTER PHONE: (B)(6). G4: PREMARKET / 510(K): K141521, K141597. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE PATIENT, DIAGNOSED WITH DEEP VEIN THROMBOSIS IN THE RIGHT LOWER EXTREMITY AND PULMONARY EMBOLISM, UNDERWENT PLACEMENT OF AN INFERIOR VENA CAVA FILTER, ASPIRATION OF THE RIGHT LOWER-EXTREMITY THROMBUS, AND CATHETER-DIRECTED THROMBOLYSIS. THE TARGET LESION WAS LOCATED IN THE RIGHT LOWER EXTREMITY. A 10.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR VESSEL DILATATION. AFTER INSERTION OF THE PTA BALLOON CATHETER, CONTRAST WAS INJECTED USING A DISPOSABLE INFLATION DEVICE. THE BALLOON DID NOT ACHIEVE FULL INFLATION, AND THE PATIENT REPORTED PAIN AND NUMBNESS IN THE AFFECTED LIMB. THE DEVICE WAS EMPTIED AND REMOVED FROM THE PATIENT. UPON INSPECTION, THE BALLOON WAS FOUND TO BE DAMAGED. A SMALL RUPTURE MEASURING LESS THAN 1MM WAS OBSERVED ON THE BALLOON SURFACE, WITH CONTRAST NOTED TO BE LEAKING IN A THIN STREAM. THE PROCEDURE WAS DISCONTINUED TO PREVENT COMPLICATIONS. THROMBOLYSIS WAS SUBSEQUENTLY CONTINUED USING A PERFUSION SYSTEM. NO FURTHER ADVERSE EVENTS WERE REPORTED, AND THE PATIENT WAS SAFELY RETURNED TO THE WARD. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 50% STENOSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE PATIENT, DIAGNOSED WITH DEEP VEIN THROMBOSIS IN THE RIGHT LOWER EXTREMITY AND PULMONARY EMBOLISM, UNDERWENT PLACEMENT OF AN INFERIOR VENA CAVA FILTER, ASPIRATION OF THE RIGHT LOWER-EXTREMITY THROMBUS, AND CATHETER-DIRECTED THROMBOLYSIS. THE TARGET LESION WAS LOCATED IN THE RIGHT LOWER EXTREMITY. A 10.0 X 80, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR VESSEL DILATATION. AFTER INSERTION OF THE PTA BALLOON CATHETER, CONTRAST WAS INJECTED USING A DISPOSABLE INFLATION DEVICE. THE BALLOON DID NOT ACHIEVE FULL INFLATION, AND THE PATIENT REPORTED PAIN AND NUMBNESS IN THE AFFECTED LIMB. THE DEVICE WAS EMPTIED AND REMOVED FROM THE PATIENT. UPON INSPECTION, THE BALLOON WAS FOUND TO BE DAMAGED. A SMALL RUPTURE MEASURING LESS THAN 1 MM WAS OBSERVED ON THE BALLOON SURFACE, WITH CONTRAST NOTED TO BE LEAKING IN A THIN STREAM. THE PROCEDURE WAS DISCONTINUED TO PREVENT COMPLICATIONS. THROMBOLYSIS WAS SUBSEQUENTLY CONTINUED USING A PERFUSION SYSTEM. NO FURTHER ADVERSE EVENTS WERE REPORTED, AND THE PATIENT WAS SAFELY RETURNED TO THE WARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583019 MUSTANG? STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE BOSTON SCIENTIFIC CORPORATION H74939171100810 0036619908 08714729795254

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male