BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOL LINE® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT JAPAN, FINAL PKGED KIT NE

    MDR report key: 24914592 · Received April 17, 2026

    Report

    Report Number
    3010617000-2026-00279
    Event Type
    Injury
    Date Received
    April 17, 2026
    Date of Event
    February 18, 2026
    Report Date
    April 17, 2026
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    NCX
    UDI-DI
    00849111075176
    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 COOL LINE CATHETER (LOT # UNKNOWN) WILL NOT BE RETURNED FOR INVESTIGATION, AS IT HAS BEEN DISPOSED OF BY THE CUSTOMER. NO DEVICE MALFUNCTION WAS REPORTED. THE EVENT OF A THROMBUS IN THE INFERIOR VENA CAVA HAS BEEN ASSESSED AS SERIOUS DUE TO THE REQUIRED MEDICAL TREATMENT TO PREVENT PERMANENT IMPAIRMENT. THE EVENT WAS ASSESSED AS PROBABLY RELATED TO THE ZOLL CATHETER DUE TO THE RELEVANT TIMING AND LOCATION OF DVT. THE PATIENT'S CRITICAL MEDICAL CONDITION AND IMMOBILITY POSSIBLY ALSO CONTRIBUTED TO DEVELOPMENT OF DVT. DVT IS A KNOWN COMPLICATION OF CENTRAL CATHETERS OF ANY KIND. PATIENTS IN A CRITICAL CONDITION ARE TREATED WITH IVTM. IN SUCH CASES, THOSE CONDITIONS MAKE THE PATIENTS PREDISPOSED TO THROMBOGENICITY. DEVELOPMENT OF THROMBUS IS A COMMON COMPLICATION IS 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].

    Description of Event or Problem · 0

    A 50-YEAR-OLD FEMALE PATIENT UNDERWENT IVTM THERAPY ON (B)(6) 2026, USING THE THERMOGARD SYSTEM FOLLOWING CARDIAC ARREST. A COOL LINE CATHETER (LOT # UNKNOWN) WAS INSERTED FROM A FEMORAL VEIN AND PLACED IN THE INFERIOR VENA CAVA. NO ADDITIONAL ADJUNCT PROCEDURES WERE PERFORMED. PRE-EXISTING BLOOD COAGULOPATHY HAD BEEN ASSESSED BEFORE HOSPITALIZATION, AND THE RESULTS WERE AVAILABLE BEFORE INITIATION OF THERAPY. THE PATIENT DID NOT RECEIVE DVT PROPHYLAXIS BEFORE DETECTION OF THROMBOSIS AND WAS NOT SYSTEMICALLY ANTICOAGULATED AT THAT TIME. THE CATHETER PLACEMENT WAS NOT ASSOCIATED WITH ANY VESSEL INJURY. THE PATIENT WAS ALSO NOTED TO HAVE A SUBARACHNOID HEMORRHAGE. ON (B)(6) 2026, AN ULTRASOUND CONFIRMED THE PRESENCE OF A THROMBUS IN THE INFERIOR VENA CAVA, WHICH WAS SUBSEQUENTLY SHOWN ON CT IMAGING TO EXTEND INTO THE RIGHT COMMON ILIAC VEIN. ANTICOAGULANT THERAPY WITH HEPARIN WAS THEN INITIATED. ON (B)(6) 2026, THE CATHETER WAS REMOVED, AND THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL. NO FURTHER INFORMATION REGARDING THE PATIENT'S CONDITION FOLLOWING TRANSFER WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497407 COOL LINE® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT JAPAN, FINAL PKGED KIT NE INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER NCX ZOLL CIRCULATION, INC. CL-2295 UNKNOWN 00849111075176

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female