BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLOSUREFAST

    MDR report key: 3060189 · Received April 11, 2013

    Report

    Report Number
    MW5029748
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 22, 2013
    Report Date
    April 10, 2013
    Manufacturer
    VNUS
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CATHETER WAS FLUSHED PRIOR TO USE BUT WIRE COULD NOT BE EXTRACTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155559 CLOSUREFAST CARDIAC CATHETER GEI VNUS 591169

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR