BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOSCULPT PTCA

    MDR report key: 1022043 · Received April 1, 2008

    Report

    Report Number
    MW5006056
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    March 6, 2008
    Report Date
    March 7, 2008
    Manufacturer
    ANGIOSCORE, INC.
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2008 CATHETER WAS LEAKING FLUID DURING USE AND UPON REMOVAL CATHETER HUB SEPARATED FROM THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOSCULPT PTCA CARDIOVASCULAR PRODUCTS LOX ANGIOSCORE, INC. F08020005

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR