BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG?

    MDR report key: 3811343 · Received May 15, 2014

    Report

    Report Number
    2134265-2014-02586
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 17, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K110122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS UNSPECIFIED FOREARM VESSEL. THE 6.0MM X 40MM, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED TO DILATE THE LESION. THE BALLOON WAS INFLATED HOWEVER, IT RUPTURED AT 24 ATMOSPHERES ON THE THIRD INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291181 MUSTANG? CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74939171060470 16676030

    Patients

    Seq Age Sex Outcome Treatment
    1 INFLATION DEVICE: ENCORE| GUIDE WIRE: RADIFOCUS