BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 17716241 · Received September 8, 2023

    Report

    Report Number
    3010617000-2023-00778
    Event Type
    Injury
    Date Received
    September 8, 2023
    Date of Event
    August 18, 2023
    Report Date
    September 8, 2023
    Manufacturer
    ZOLL CIRCULATION INC
    Product Code
    NCX
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ICY CATHETER ASSOCIATED WITH THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. SINCE THE DEVICE WAS NOT RETURNED, AN INVESTIGATION COULD NOT BE PERFORMED BY ZOLL, AND A ROOT CAUSE COULD NOT BE DETERMINED. EVENT OF SWELLING WAS ASSESSED AS NOT SERIOUS. BASED ON THE PROVIDED INFORMATION, THE EVENT OF SWELLING WAS POSSIBLY RELATED TO THE ZOLL CATHETER DUE TO RELEVANT TIMING AND LOCATION. SWELLING SUBCUTANEOUS TISSUE AROUND THE ZOLL CATHETER IS AN ANTICIPATED EVENT AND COULD POTENTIALLY OCCUR WITH THE USAGE OF ANY CATHETER. THE EVENT IS POSSIBLY RELATED TO THE DEVICE AND CASUALLY RELATED TO THE PROCEDURE. EVENT OF DVT WAS ASSESSED AS SERIOUS BECAUSE BASED ON AVAILABLE INFORMATION, TREATMENT WAS REQUIRED. EVENT ASSESSED AS PROBABLY RELATED TO THE ZOLL CATHETER DUE TO RELEVANT TIMING AND LOCATION 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 PATIENT POPULATIONS. 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 USAGE OF ANY CATHETER. THE EVENT IS PROBABLY RELATED TO THE DEVICE AND PROBABLY RELATED TO THE PROCEDURE. THE PATIENT'S DEATH WAS CONFIRMED (BRAIN DEATH) AFTER IVTM THERAPY ENDED AND RESOLUTION OF THE BLOOD CLOT. ACCORDING TO THE REPORTER, THE PATIENT OUTCOME OF DEATH WAS NOT ATTRIBUTED TO THE ZOLL DEVICES. EVENT OF DEATH WAS SERIOUS BECAUSE IT MET CRITERIA FOR SERIOUSNESS (DEATH). DEATH WAS NOT RELATED TO THE ZOLL DEVICE.

    Description of Event or Problem · 0

    ON (B)(6) 2023, IVTM THERAPY USING THE ICY CATHETER (LOT: 185168) BEGAN FOR THE MANAGEMENT OF THE PATIENT'S TEMPERATURE. THE CATHETER WAS INSERTED IN THE RIGHT-SIDE UPPER LEG OF A CPA PATIENT. THE TARGET TEMPERATURE WAS SET AT 34 C FOR 24 HOURS (COOLING). AFTER THAT, TARGET TEMPERATURE WAS SET AT 36.5 C FOR 24 HOURS (REWARMING). ANTI-COAGULANTS WERE NOT USED. ON (B)(6) 2023, IVTM THERAPY ENDED, AND THE CATHETER WAS REMOVED ACCORDING TO THE INSTRUCTION MANUAL. THE CUSTOMER HAD NO COMPLAINTS ABOUT THE CATHETER AND CATHETER WAS DISCARDED. ON (B)(6) 2023, D-DIMER LEVELS ROSE, AND AN ULTRASOUND WAS DONE. SWELLING OF THE LEGS WAS CONFIRMED. THE BLOOD CLOT WAS OBSERVED FROM THE INSERTION SITE TO THE FEMORAL VEIN AND GREAT SAPHENOUS VEIN. ANTICOAGULANT THERAPY OF HEPARIN WAS STARTED TO TREAT THE CLOT. D-DIMER LEVELS DECREASED, AND THE BLOOD CLOT DISAPPEARED. IT IS UNKNOWN IF THE PATIENT RECEIVED ANY TREATMENT TO ALLEVIATE THE SWELLING. LATER, THE PATIENT'S DEATH WAS CONFIRMED (BRAIN DEATH). THE TIME PERIOD BETWEEN THE END OF IVTM THERAPY AND RESOLUTION OF THE BLOOD CLOT, AND WHEN THE PATIENT WAS DETERMINED TO BE BRAIN DEAD IS UNKNOWN. PER THE CUSTOMER, PATIENT'S BRAIN DEATH AND THE USE OF THERMOGARD WAS UNRELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1501861 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION INC 8700-0782-03 185168

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other