BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG?

    MDR report key: 24262110 · Received February 4, 2026

    Report

    Report Number
    2124215-2026-06495
    Event Type
    Malfunction
    Date Received
    February 4, 2026
    Date of Event
    January 9, 2026
    Report Date
    February 4, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729793786
    PMA / PMN Number
    K103751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B - PRO CODE (PRODUCT CODE): FGE, LIT. E1 - INITIAL REPORTER ADDRESS 1: (B)(6). G4 - PREMARKET / 510(K): K103751, K110122, K141521.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED FISTULA. A 7.0 X 150, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION AT 6 ATMOSPHERES, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321546 MUSTANG? STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE BOSTON SCIENTIFIC CORPORATION H74939171071510 0035878684 08714729793786

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown