BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICY INTRAVASCULAR HEAT EXCHANGE CATHETER KIT EU APPLAUSE CUSTOM LUER (HEPARIN)

    MDR report key: 7666041 · Received July 6, 2018

    Report

    Report Number
    7666041
    Event Type
    Malfunction
    Date Received
    July 6, 2018
    Date of Event
    April 12, 2018
    Report Date
    June 28, 2018
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    NCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ELDERLY MALE STATUS POST MVC (MOTOR VEHICLE CRASH) AND CARDIAC CATHETERIZATION VIA RIGHT GROIN SITE. PHYSICIAN INSERTING ICY CATHETER INTO PATIENT TO INITIATE TARGETED TEMPERATURE MANAGEMENT. UPON INSERTION INTO THE LEFT FEMORAL SITE, THE BALLOON PORTION OF THE CATHETER WAS NOTED TO FILL WITH BLOOD. PER THE MD, THIS WAS A SIGN OF A TEAR IN THE BALLOON. THE CATHETER WAS REMOVED FROM THE PATIENT AND A NEW CATHETER WAS INSERTED WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509586 ICY INTRAVASCULAR HEAT EXCHANGE CATHETER KIT EU APPLAUSE CUSTOM LUER (HEPARIN) SYSTEM, HYPOTHERMIA, INTRAVENOUS, COOLING NCX ZOLL CIRCULATION, INC. IC-3893AE 74959

    Patients

    Seq Age Sex Outcome Treatment
    1 24455 DA