BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOLL IVTM QUATTRO CATHETER

    MDR report key: 18094570 · Received November 8, 2023

    Report

    Report Number
    3010617000-2023-00981
    Event Type
    Injury
    Date Received
    November 8, 2023
    Date of Event
    October 16, 2023
    Report Date
    November 8, 2023
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075275
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE QUATTRO 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 PATIENT WAS IN A HIGH-RISK CATEGORY FOR DVT DUE TO IMMOBILITY AFTER CARDIAC ARREST. THE PATIENT IS CURRENTLY IN STABLE CONDITION. THE EVENT OF DVT WAS ASSESSED AS SERIOUS. THE EVENT WAS ASSESSED AS PROBABLY RELATED TO THE ZOLL CATHETER DUE TO THE RELEVANT TIMING AND 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. THE DEVELOPMENT OF THROMBUS IS A COMMON COMPLICATION IN SUCH A 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 EVENT IS PROBABLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE.

    Description of Event or Problem · 0

    A MALE PATIENT WHO HAD BEEN RESUSCITATED FROM CARDIAC ARREST WAS PLACED INTO CONTROLLED HYPOTHERMIA BY IVTM THERAPY. THERE WAS NO BLOOD COAGULOPATHY PERFORMED BEFORE THE INITIATION OF IVTM THERAPY. A QUATTRO CATHETER (LOT # UNKNOWN) WAS SMOOTHLY INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN IN ONE ATTEMPT. THERE WERE NO OTHER ADJUNCTIVE TEMPERATURE MANAGEMENT OR RELATIVE PROCEDURES PERFORMED, AND NO OTHER CENTRAL VENOUS CATHETERS (CVC) WERE PLACED BEFORE UTILIZING THE ZOLL CATHETER. THE CATHETER WAS IN THE PATIENT FOR FOUR DAYS (96 HOURS), AND IT FUNCTIONED AS INTENDED DURING THE TREATMENT. TWO DAYS AFTER COMPLETION OF THE THERAPY, A ROUTINE BLOOD DRAW REVEALED ELEVATED D-DIMER. THE PATIENT WAS IN A HIGH-RISK CATEGORY FOR DVT DUE TO IMMOBILITY AFTER CARDIAC ARREST. THE DVT PROPHYLAXIS USED ON THE PATIENT WAS HEPARIN PERFUSOR WITH 500 IE. U/H. THE PATIENT'S LEG WAS SLIGHTLY SWOLLEN BUT HAD NO OTHER SYMPTOMS. AN ULTRASOUND EXAMINATION WAS PERFORMED AND REVEALED A 3 CM-LONG DEEP VEIN THROMBOSIS (DVT) ALONG THE LOWER LEG. THE CATHETER WAS ALREADY REMOVED AND DISCARDED WHEN THE THROMBOSIS WAS DISCOVERED. THERE WAS NO THROMBOGENIC MATERIAL OBSERVED ON THE CATHETER. TO MITIGATE THE DVT, THE DOSE OF HEPARIN WAS INCREASED. THE PATIENT IS CURRENTLY STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836897 ZOLL IVTM QUATTRO CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-4593AE UNKNOWN 00849111075275

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other