BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG

    MDR report key: 20896251 · Received December 10, 2024

    Report

    Report Number
    2124215-2024-77927
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    December 2, 2024
    Report Date
    December 10, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729793786
    PMA / PMN Number
    K103751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: PRODUCT CODE - LIT. G4: PMA/510(K) # FIELD ON 3500A FORM - K110122, K141521.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE PERIPHEARAL ARTERY. A 7.0 X 150, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON WAS RUPTURED DURING THE FIRST INFLATION AT 16 ATMOSPHERES. THE DEVICE WAS REMOVED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONA REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2534321 MUSTANG STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE BOSTON SCIENTIFIC CORPORATION H74939171071510 0028976238 08714729793786

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown