BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORDIS

    MDR report key: 281299 · Received June 7, 2000

    Report

    Report Number
    281299
    Event Type
    Injury
    Date Received
    June 7, 2000
    Date of Event
    May 4, 2000
    Report Date
    May 4, 2000
    Manufacturer
    CORDIS ENDOVASCULAR
    Product Code
    MKI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RIGHT ARM PAINFUL AND COLD SINCE 12.00-COOL AND PULSELESS. INITIAL ATTEMPTS TO PERFORM AN ANGIO VIA LEFT GROIN SHOWED COMMON ILIAC ARTERY OCCLUSION. PROCEDURE WAS SUBSEQUENTLY PERFORMED VIA LEFT BRACHIAL ARTERY. ATTEMPT TO REMOVE LEFT FEMORAL CATHETER AND PLACE VASO-SEAL RESULTED IN "KNOTTED" GUIDEWIRE. ATTEMPT TO REMOVE GUIDEWIRE RESULTED IN CORE OF GUIDEWIRE BREAKING, LEAVING A PORTION OF THE WIRE IN THE ARTERY. THIS NECESSITATED SURGERY FOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORDIS EMERALD GUIDEWIRE MKI CORDIS ENDOVASCULAR 502-560 F0200792

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention VASOSEAL