BEUDAMED
    FDA Adverse Event Other Summary report: N

    MARK V

    MDR report key: 531131 · Received May 26, 2004

    Report

    Report Number
    531131
    Event Type
    Other
    Date Received
    May 26, 2004
    Date of Event
    April 20, 2004
    Report Date
    May 24, 2004
    Manufacturer
    MEDRAD, INC.
    Product Code
    DXT
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT AN ARCH AORTOGRAM, SELECTIVE CATHETERIZATION OF RIGHT INNOMINATE ARTERY WITH INTRACEREBRAL ARTERIOGRAPHY AND CAROTID ARTERIOGRAPHY, SELECTIVE CATHETERIZATION OF LEFT COMMON CAROTID, WITH LEFT COMMON CAROTID ARTERIOGRAM, INTRACEREBRAL ARTERIOGRAM AND SELECTIVE CATHETERIZATION OF LEFT SUBCLAVIAN AND LEFT VERTEBRAL ARTERIOGRAM. DURING THE FIRST RUN OF THE RIGHT COMMON CAROTID ARTERY, THE MED RAD INJECTOR MADE "WHOOSHING" SOUND AS IT INJECTED. THE INJECTOR LINES WERE CHECKED AND THERE WAS NO LEAK. THE SYRINGE AND INJECTOR SLEEVE WERE CHECKED AND THERE WAS NO LEAK. THE SYRINGE AND INJECTOR SLEEVE WERE CHANGED OUT AT THIS POINT. THE TEST CONTINUED ON THE RIGHT SIDE WITH NO CHANGE IN THE PT'S VITAL SIGNS. THE CATHETER WAS BROUGHT DOWN INTO THE LEFT PROXIMAL SUBCLAVIAN AND AN AXILLARY PICTURE WAS OBTAINED. AT THIS STAGE, IT WAS SUDDENLY NOTICED THAT THE PT HAD BECOME DYSARTHRIC. PT WAS MOVING ALL LIMBS APPROPRIATELY AND WAS FULLY RESPONSIVE. THE MACHINE WAS CHECKED BY MED RAD TECHNICIAN AND FOUND TO BE OPERATING CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARK V MEDRAD INJECTOR DXT MEDRAD, INC. PRM 220 60 051 *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other