BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG?

    MDR report key: 22898367 · Received August 26, 2025

    Report

    Report Number
    2124215-2025-59682
    Event Type
    Malfunction
    Date Received
    August 26, 2025
    Date of Event
    August 8, 2025
    Report Date
    August 26, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    UDI-DI
    08714729794578
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4 - PREMARKET / 510(K) #: K103751, K110122, K141521.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A MUSTANG 7.0 X 150, 75CM WAS ADVANCED FOR DILATATION. DURING TREATMENT, BALLOON BURST AT 25ATM AFTER A MINUTE LATER. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1631017 MUSTANG? STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS LIT BOSTON SCIENTIFIC CORPORATION H74939171071570 0036559896 08714729794578

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male