BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRO® JAPAN, INTRAVASCULAR HEAT EXCHANGE CATHETER KIT JAPAN CUSTOM LUER

    MDR report key: 25073681 · Received May 4, 2026

    Report

    Report Number
    3010617000-2026-00275
    Event Type
    Injury
    Date Received
    May 4, 2026
    Date of Event
    March 6, 2026
    Report Date
    May 4, 2026
    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 QUATTRO CATHETER IN THE COMPLAINT WILL NOT BE RETURNED FOR INVESTIGATION, AS IT WAS DISCARDED BY THE CUSTOMER. NO DEVICE MALFUNCTION WAS REPORTED. EVENT OF DEEP VEIN THROMBOSIS (DVT) WAS ASSESSED AS SERIOUS DUE TO THE REQUIRED MEDICAL TREATMENT TO PREVENT A PERMANENT IMPAIRMENT. THE EVENT WAS ASSESSED AS PROBABLY RELATED TO THE ZOLL CATHETER DUE TO THE RELEVANT LOCATION OF DVT. THE PATIENT'S TRAUMA, POST-CARDIAC ARREST MEDICAL CONDITION AND IMMOBILITY POSSIBLY ALSO CONTRIBUTED TO THE DEVELOPMENT OF DVT. THE EVENT WAS DIAGNOSED 6 DAYS AFTER CATHETER REMOVAL. 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]. EVENT OF DEATH WAS SERIOUS BECAUSE IT MET CRITERIA FOR SERIOUSNESS (DEATH). THE PATIENT WAS IN A CRITICAL CONDITION AND EVENTUALLY EXPIRED. ACCORDING TO THE REPORTER, THE PATIENT DIED FROM BRAIN DEATH. THE PHYSICIAN DETERMINED THAT THERE WAS NO RELATIONSHIP BETWEEN THE DEATH AND THE THROMBOSIS. USUALLY, CRITICALLY ILL PATIENTS RECEIVE IVTM THERAPY AND MORTALITY RATE IS HIGH. PROBABLY OUTCOME DEATH RELATED TO THE PATIENT'S CLINICAL CONDITION AND NOT TO IVTM THERAPY.

    Description of Event or Problem · 0

    A PATIENT WHO SUSTAINED TRAUMA AND EXPERIENCED CARDIAC ARREST UNDERWENT TARGETED TEMPERATURE MANAGEMENT (TTM) THERAPY ON (B)(6) 2026 USING A QUATTRO CATHETER (LOT # UNKNOWN). PRIOR TO HOSPITALIZATION, THE PATIENT HAD NO CONDITIONS THAT WOULD RENDER THEM NON-AMBULATORY. THE PATIENT WAS SYSTEMICALLY ANTICOAGULATED, AND NO ADJUNCT PROCEDURES WERE PERFORMED. BLOOD COAGULOPATHY WAS ASSESSED PRIOR TO HOSPITALIZATION, AND RESULTS WERE AVAILABLE BEFORE INITIATION OF THERAPY. HEPARIN CALCIUM WAS ADMINISTERED SUBCUTANEOUSLY AS PROPHYLAXIS AGAINST THROMBOSIS. THE PATIENT WAS NOT CONSIDERED HIGH RISK FOR DEEP VEIN THROMBOSIS (DVT), AS THERE WAS NO HISTORY OF DRUG OR ALCOHOL ABUSE OR PRIOR THROMBOTIC EVENTS. IVTM THERAPY ENDED ON (B)(6) 2026, AND THE CATHETER WAS REMOVED. THE CATHETER FUNCTIONED AS INTENDED THROUGHOUT THERAPY, WITH NO MALFUNCTIONS. ON (B)(6) 2026, A THROMBUS IN THE INFERIOR VENA CAVA WAS CONFIRMED BY COMPUTED TOMOGRAPHY (CT) SCAN; THE LENGTH OF THE THROMBOSIS WAS NOT REPORTED. NO VESSEL INJURY ATTRIBUTABLE TO THE CATHETER WAS IDENTIFIED. HEPARIN SODIUM WAS CONTINUOUSLY INFUSED TO MITIGATE THE DVT. THE PATIENT SUBSEQUENTLY DIED DUE TO BRAIN DEATH. THE PHYSICIAN DETERMINED THAT THERE WAS NO RELATIONSHIP BETWEEN THE DEATH AND THE THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323946 QUATTRO® JAPAN, INTRAVASCULAR HEAT EXCHANGE CATHETER KIT JAPAN CUSTOM LUER INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER NCX ZOLL CIRCULATION, INC. IC-4593 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death