BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WORKHORSE II PTA BALLOON CATHETER

    MDR report key: 2211256 · Received July 12, 2011

    Report

    Report Number
    1319211-2011-00065
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 17, 2011
    Report Date
    July 12, 2011
    Manufacturer
    ANGIODYNAMICS
    Product Code
    DQY
    PMA / PMN Number
    K032069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE FOR INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH.

    Description of Event or Problem · 1

    AFTER SUCCESSFULLY COMPLETING A DECLOT WITH A PTA BALLOON, THE BALLOON BECAME STUCK IN THE SHEATH AND BROKE UPON REMOVAL FROM THE PT. WHILE THE PHYSICIAN WAS REMOVING THE DEVICE FROM THE PT, USING A CURVED CLAMP IN LIEU OF A SNARE, THEY RIPPED THE VESSEL. THERE WAS NO HARM OR INJURY REPORTED TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WORKHORSE II PTA BALLOON CATHETER PTA BALLOON CATHETER DQY ANGIODYNAMICS NA 974016

    Patients

    Seq Age Sex Outcome Treatment
    1