BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG

    MDR report key: 8638358 · Received May 23, 2019

    Report

    Report Number
    2134265-2019-05759
    Event Type
    Malfunction
    Date Received
    May 23, 2019
    Date of Event
    May 2, 2019
    Report Date
    May 23, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    UDI-DI
    08714729793458
    PMA / PMN Number
    K103751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0 X 150, 135 CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432099 MUSTANG CATHETER, BILIARY, DIAGNOSTIC LIT BOSTON SCIENTIFIC CORPORATION 24672 0021695951 08714729793458

    Patients

    Seq Age Sex Outcome Treatment
    1