BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 19736172 · Received July 12, 2024

    Report

    Report Number
    3010617000-2024-00542
    Event Type
    Injury
    Date Received
    July 12, 2024
    Date of Event
    June 19, 2024
    Report Date
    July 12, 2024
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    NCX
    UDI-DI
    00849111075251
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ICY CATHETER ASSOCIATED WITH THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE CUSTOMER. THEREFORE, A PHYSICAL INVESTIGATION OF THE CATHETER COULD NOT BE PERFORMED. THE EVENT OF DVT WAS ASSESSED AS SERIOUS. EVEN THOUGH THE EVENT WAS DIAGNOSED AS FINDING WITH A ROUTINE TEST, THE PATIENT DIDN'T HAVE SYMPTOMS, AND TREATMENT WAS NOT REQUIRED, 4 CM THROMBUS IN THE VENA CAVA INFERIOR IS A LIFE-THREATENING MEDICAL CONDITION. THE EVENT WAS ASSESSED AS PROBABLY RELATED TO THE ZOLL CATHETER DUE TO THE RELEVANT TIMING AND RELEVANT LOCATION OF DVT. AT THE SAME TIME, THE PATIENT'S POST-CARDIAC ARREST CONDITION AND IMMOBILITY POSSIBLY CONTRIBUTED TO THE DEVELOPMENT OF THE CURRENT CONDITION OF DVT. DVT IS A KNOWN COMPLICATION OF CENTRAL CATHETERS OF ANY KIND. PATIENTS IN CRITICAL CONDITION ARE TREATED WITH IVTM. IN SUCH CASES, THOSE CONDITIONS MAKE THE PATIENTS PREDISPOSED TO THROMBOGENICITY. DEVELOPMENT OF THROMBUS IS A COMMON COMPLICATION IN SUCH PATIENT POPULATION. CRITICALLY ILL PATIENTS ARE AT INCREASED RISK OF VTE BECAUSE OF THE PRESENCE OF MULTIPLE PREDISPOSING FACTORS [W. GEERTS, ET AL. VENOUS THROMBOEMBOLISM AND ITS PREVENTION IN CRITICAL CARE. J CRIT CARE, 17 (2002), PP. 95-104]. THE RATE OF THROMBOSIS FOR CRITICAL CARE PATIENTS RECEIVING CVCS RANGES FROM 20 TO 30%, PATIENTS WITH PERIPHERAL CENTRAL CATHETERS HAD A SIGNIFICANTLY HIGHER INCIDENCE RATE OF DVT THAN PATIENTS WITH CVC (27.2% VS 9.6%, P=0.0012). THE RATE OF DVT IN THE PATIENT POPULATION RECEIVING IVTM POST-CARDIAC ARREST IS 1.7%. FOUR RANDOMIZED CONTROLLED CLINICAL TRIALS CONDUCTED IN A TOTAL OF 943 PATIENTS SHOWED THAT THERE WAS NO DIFFERENCE IN THE DVT RATE WHEN COMPARING ZOLL IVTM CATHETERS TO STANDARD CVCS. THE RATE OF DVT IN THE PATIENT POPULATION RECEIVING SURFACE COOLING HAS BEEN REPORTED BETWEEN 3 AND 15%. TIMELY ADMINISTRATION OF PROPHYLACTIC ANTICOAGULATION IS SAFE AND SIGNIFICANTLY REDUCES DVT RATES IN HIGH-RISK PATIENT POPULATIONS [ZOLL WHITE PAPER ON DVT]. DVT IS AN ANTICIPATED EVENT AND COULD POTENTIALLY OCCUR WITH THE USAGE OF ANY CATHETER. THE REPORTED EVENT IS PROBABLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE.

    Description of Event or Problem · 0

    A PATIENT WHO HAD BEEN RESUSCITATED FROM CARDIAC ARREST WAS PLACED INTO CONTROLLED HYPOTHERMIA BY IVTM THERAPY. AN ICY CATHETER (LOT # UNKNOWN) WAS SMOOTHLY INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN IN ONE INSERTION ATTEMPT. THERE WAS NO BLOOD COAGULOPATHY PERFORMED BEFORE THE INITIATION OF IVTM THERAPY. NO ADJUNCTIVE TEMPERATURE MANAGEMENT OR RELATIVE PROCEDURES WERE PERFORMED, AND NO OTHER CENTRAL VENOUS CATHETERS (CVC) WERE PLACED BEFORE UTILIZING THE ZOLL CATHETER. THE CATHETER FUNCTIONED AS INTENDED DURING ITS DWELL TIME OF FOUR DAYS. SIX DAYS AFTER POST-REANIMATION TREATMENT, AND ONE DAY AFTER THE CATHETER WAS REMOVED, DEEP VEIN THROMBOSIS (DVT) WAS NOTICED AS AN INCIDENTAL FINDING DURING A CT SCAN. THE PATIENT DIDN'T HAVE ANY SYMPTOMS OF DVT. THE MEASURED LENGTH OF THE THROMBOSIS WAS 4 CENTIMETERS, AND IT WAS LOCATED IN THE VENA CAVA INFERIOR (VCI). PER THE CUSTOMER, THE PATIENT WASN'T IN A HIGH-RISK CATEGORY FOR DVT. THE PATIENT HAD RECEIVED DVT PROPHYLAXIS IN THE FORM OF 40 MG (0.4 ML) OF ENOXAPARIN DAILY, WHICH IS STANDARD FOR TRAUMATIC BRAIN INJURY (TBI) PATIENTS. NO SPECIFIC INTERVENTION WAS PERFORMED TO MITIGATE THE DVT AFTER ITS DISCOVERY. THE PATIENT IS CURRENTLY STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167413 ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT EU APPLAUSE CUSTOM LUER (HEPARIN) INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER NCX ZOLL CIRCULATION, INC. IC-3893AE UNKNOWN 00849111075251

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other