BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 25073680 · Received May 4, 2026

    Report

    Report Number
    3010617000-2026-00276
    Event Type
    Injury
    Date Received
    May 4, 2026
    Date of Event
    March 14, 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. THE EVENT OF DEEP VEIN THROMBOSIS (DVT) WAS 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 THE 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 PATIENT UNDERWENT TARGETED TEMPERATURE MANAGEMENT (TTM) ON (B)(6) 2026 USING A QUATTRO CATHETER (LOT#: UNKNOWN). NO ADJUNCT PROCEDURES WERE PERFORMED. THE PATIENT WAS NOT SYSTEMICALLY ANTICOAGULATED. BLOOD COAGULOPATHY WAS PERFORMED PRIOR TO HOSPITALIZATION, AND RESULTS WERE AVAILABLE BEFORE THERAPY INITIATION. THE PATIENT DID NOT RECEIVE DVT PROPHYLAXIS. ON (B)(6) 2026, AN ULTRASOUND SCAN CONFIRMED THE PRESENCE OF A THROMBUS IN THE INFERIOR VENA CAVA; THE LENGTH OF THE THROMBOSIS WAS NOT REPORTED. NO CATHETER-RELATED VESSEL INJURY WAS IDENTIFIED. HEPARIN SODIUM WAS ADMINISTERED VIA CONTINUOUS INFUSION TO MITIGATE THE DVT. THE CATHETER WAS SUBSEQUENTLY REMOVED AND HAD FUNCTIONED AS INTENDED THROUGHOUT THERAPY, WITH NO REPORTED MALFUNCTIONS. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL; THEREFORE, THE CURRENT CLINICAL STATUS OF THE PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323945 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 Other