BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORDIS SV-5 X 300 CM

    MDR report key: 1003966 · Received February 26, 2008

    Report

    Report Number
    MW5005694
    Event Type
    Injury
    Date Received
    February 26, 2008
    Date of Event
    February 6, 2008
    Report Date
    February 15, 2008
    Manufacturer
    CORDIS - ENDOVASCULAR
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN ANGIOGRAM WAS BEING DONE IN INTERVENTIONAL BY DR. HE WAS ATTEMPTING TO GET THROUGH A TOTAL OCCLUSION OF A LEFT SUPERFICIAL ARTERY WITH A CORDIS SV-5 .018 X 300 CM WIRE WHEN A PIECE OF THE WIRE BROKE OFF AT ABOUT THE LEFT POPLITEAL ARTERY LEVEL BUT IN THE SUBINTIMAL SPACE NOT WITHIN THE ARTERY. DR WAS NOT ABLE TO GET THROUGH THE TOTAL OCCLUSION AND BACK INTO THE TRUE LUMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORDIS SV-5 X 300 CM GUIDE WIRE DQX CORDIS - ENDOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other