BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOSCULPT

    MDR report key: 3231141 · Received June 26, 2013

    Report

    Report Number
    3231141
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ANGIOSCORE, INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    USING ANGIOSCORE BALLOON, UPON ATTEMPTED REMOVAL OF BALLOON, BALLOON CAME UNATTACHED FROM SHAFT OF DEVICE IN THE CIRCUMFLEX ARTERY RESULTING IN SNARE PROCEDURE WHICH ULTIMATELY FAILED REQUIRING STENTING OF THE AREA WITH BALLOON STILL IN PLACE. PATIENT IS DOING WELL. NO FURTHER ISSUES.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290658 ANGIOSCULPT CATHETER DQY ANGIOSCORE, INC. * F13030033

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR