BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG

    MDR report key: 20692026 · Received November 14, 2024

    Report

    Report Number
    2124215-2024-71874
    Event Type
    Malfunction
    Date Received
    November 14, 2024
    Date of Event
    November 1, 2024
    Report Date
    November 14, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729793748
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B PRO CODE (PRODUCT CODE): FGE, LIT. G4 PREMARKET / 510(K) #: K103751, K110122, K141521.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 7.0 X 200, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BURST BEFORE REACHING THE NOMINAL PRESSURE. THE BALLOON WAS REMOVED SUCCESSFULLY, AND THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. NO COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2217686 MUSTANG STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE BOSTON SCIENTIFIC CORPORATION H74939171072010 0028659364 08714729793748

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown