BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG?

    MDR report key: 22842565 · Received August 19, 2025

    Report

    Report Number
    2124215-2025-56479
    Event Type
    Malfunction
    Date Received
    August 19, 2025
    Date of Event
    July 16, 2025
    Report Date
    October 1, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K141521
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: PRO CODE (PRODUCT CODE): FGE, LIT REPORTED HERE AS PRO CODE EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD. G4: PREMARKET / 510(K) #: K141521, K141597 REPORTED HERE AS PREMARKET /510(K) # EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD.

    Additional Manufacturer Narrative · 0

    D2B: PRO CODE (PRODUCT CODE): FGE, LIT. G4: PREMARKET / 510(K) #: K141521, K141597. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE PHYSICIAN DETAILS, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 7.0 X 100, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, WHEN THE BALLOON WAS REMOVED, IT WAS FOUND THAT THE TIP OF THE BALLOON WAS DETACHED. THE DEVICE WAS PULLED OUT FROM THE PATIENT AND THE BALLOON TIP WAS LOCATED IN THE SHEATH, AND THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 7.0 X 100, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, WHEN THE BALLOON WAS REMOVED, IT WAS FOUND THAT THE TIP OF THE BALLOON WAS DETACHED. THE DEVICE WAS PULLED OUT FROM THE PATIENT AND THE BALLOON TIP WAS LOCATED IN THE SHEATH, AND THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1394557 MUSTANG? STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE BOSTON SCIENTIFIC CORPORATION H74939171071070 0034890211

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown