BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUSTANG?

    MDR report key: 22035938 · Received May 16, 2025

    Report

    Report Number
    2124215-2025-28476
    Event Type
    Injury
    Date Received
    May 16, 2025
    Date of Event
    February 1, 2025
    Report Date
    May 16, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729793335
    PMA / PMN Number
    K141521
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 - DATE OF EVENT: USED 02/01/2025 AS THE EXACT EVENT DATE WAS NOT REPORTED. D2B - PRO CODE (PRODUCT CODE): FGE, LIT. E1 - INITIAL REPORTER ADDRESS 1: (B)(6). G4 - PREMARKET / 510(K) #: K141521, K141597. DETAILED INITIAL REPORTER AND ADDITIONAL EVENT DETAILS WERE NOT PROVIDED TO BSC. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BALLOON WAS DIFFICULT TO WITHDRAW, REQUIRING INCISION FOR REMOVAL. THE PATIENT PRESENTED WITH PERIPHERAL VASCULAR STENOSIS CAUSED BY UREMIA UNDERWENT BALLOON DILATATION OF AN ARTERIOVENOUS FISTULA. A 6.0 X 40, 75CM MUSTANG BALLOON WAS SELECTED FOR USE. HOWEVER, AFTER THE DILATION DURING THE PROCEDURE, THE BALLOON DEFORMED AND WAS DIFFICULT TO WITHDRAW. THE DEVICE WAS REMOVED BY INCISION, AND THE PROCEDURE WAS COMPLETED WITH OTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1749492 MUSTANG? STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE BOSTON SCIENTIFIC CORPORATION H74939171060470 0032177178 08714729793335

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention