BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICY CENTRAL VENOUS HEAT EXCHANGE CATHETER

    MDR report key: 3011019 · Received March 12, 2013

    Report

    Report Number
    3003793491-2013-00385
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    April 20, 2012
    Report Date
    April 28, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    NCX
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP HAS NOT RECEIVED THE PRODUCT FOR EVAL. IF PRODUCT IS RETURNED TO THE MFR, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ENTRY SITE AND VEIN ACCESS HAD TO BE WIDENED UPON REMOVAL OF THE ICY CATHETER FROM THE FEMORAL VEIN, IN ORDER TO AVOID LEAVING FRAGMENTS IN THE PT'S ANATOMY. INITIALLY THE ENTIRELY DEFLATED/ ASPIRATED CATHETER COULD ONLY BE PULLED OUT UP TO THE PROXIMAL BALLOON. AFTER FEELING THE VEIN, IT WAS POSSIBLE TO RECOVER THE ENTIRE CATHETER, HOWEVER THE MIDDLE BALLOON OF THE CATHETER WAS DETACHED AND WAS ONLY CONNECTED TO THE CATHETER AT ITS DISTAL END. THE FOLLOWING DISTAL BALLOON, SIMILAR TO THE PROXIMAL BALLOON, WERE BOTH UNDAMAGED. IN THIS CASE, BEYOND EXPANSION OF THE ENTRY SITE AND THE VEIN DESCRIBED ABOVE, NO FURTHER HARM WAS SUFFERED BY THE PT. THE PRODUCT WAS DISCARDED BY THE HOSPITAL FACILITY. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104468 ICY CENTRAL VENOUS HEAT EXCHANGE CATHETER INTRAVASCULAR HEATING/COOLING CATHETER NCX ZOLL CIRCULATION, INC. IC-3893AE 24826

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention