BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG?

    MDR report key: 22742350 · Received August 7, 2025

    Report

    Report Number
    2124215-2025-53681
    Event Type
    Malfunction
    Date Received
    August 7, 2025
    Date of Event
    July 11, 2025
    Report Date
    August 7, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729793717
    PMA / PMN Number
    K103751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: PRO CODE (PRODUCT CODE): FGE, LIT. G4: PREMARKET/510(K): K103751, K110122.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TIP DAMAGE OCCURRED. A 4.0 X 100, 135 CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE. DURING INSERTION INTO THE GUIDE CATHETER, IT WAS NOTED THAT THE TIP HAS A BEVELED CUT. THE DEVICE WAS NOT USED IN THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700025 MUSTANG? STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE BOSTON SCIENTIFIC CORPORATION H74939171041010 0034670400 08714729793717

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female