BEUDAMED
    FDA Adverse Event Death Summary report: N

    7F VECTORX/EBU4.0

    MDR report key: 71051 · Received February 20, 1997

    Report

    Report Number
    1220452-1997-00001
    Event Type
    Death
    Date Received
    February 20, 1997
    Date of Event
    January 27, 1997
    Report Date
    February 17, 1997
    Manufacturer
    MEDTRONIC INTERVENTIONAL VASCULAR, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DISSECTION OF PROXIMAL LEFT MAIN CORONARY ARTERY BEFORE THE FIRST DYE INJECTION. PT WENT TO CORONARY ARTERY BYPASS GRAFT SURGERY (CABG) AND WAS OKAY. DISSEMINATED INTERVASCULAR COAGULATION (DIC) POST CABG AND PT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7F VECTORX/EBU4.0 GUIDING CATHETER DYB MEDTRONIC INTERVENTIONAL VASCULAR, INC. S27333 46787

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death