BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDRAD MARK V PLUS

    MDR report key: 2003524 · Received February 22, 2011

    Report

    Report Number
    MW5019533
    Event Type
    Death
    Date Received
    February 22, 2011
    Date of Event
    August 27, 2010
    Report Date
    February 22, 2011
    Manufacturer
    MEDRAD, INC.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) FEMALE ADMITTED FOR ELECTRIC CARDIAC CATHETERIZATION ON (B)(6) 2010. RISKS AND ALTERNATIVES OF PROCEDURE, AND CONSCIOUS SEDATION EXPLAINED TO PATIENT. CONSENT OBTAINED, PT BROUGHT INTO CATH LAB. PUNCTURE SITES PREPPED, DRAPED USUAL FASHION. RIGHT FEMORAL ACCESS OBTAINED, TEMPORARY PACEMAKER PLACED. VENTRICULOGRAPHY INITIATED. INJECTOR TRIGGERED TO RELEASE DYE/CONTRAST FOR THREE SECONDS. NO DYE OBSERVED IN THE VENTRICLE. PT WENT INTO VENTRICULAR FIBRILLATION, INTUBATED AND AGGRESSIVELY RESUSCITATED. AFTER 30 MINUTES CODE WAS CALLED, PT PRONOUNCED AT 10:52 AM. (PT DEATH ASSOCIATED WITH INTRAVASCULAR AIR EMBOLUS WHILE BEING CARED FOR IN FACILITY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDRAD MARK V PLUS MEDRAD DXT MEDRAD, INC. SYS 500-P1

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death