BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG?

    MDR report key: 22956440 · Received September 3, 2025

    Report

    Report Number
    2124215-2025-60661
    Event Type
    Malfunction
    Date Received
    September 3, 2025
    Date of Event
    August 7, 2025
    Report Date
    September 3, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729794103
    PMA / PMN Number
    K103751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RADIAL VEIN. A 4.0 X 40, 40 CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, THE BALLOON WAS NOT INFLATED DUE TO A PINHOLE NOTED DURING FLUSHING. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1336299 MUSTANG? STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE BOSTON SCIENTIFIC CORPORATION H74939171040440 0035762763 08714729794103

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown