BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23873912 · Received December 22, 2025

    Report

    Report Number
    3010617000-2025-00892
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    November 24, 2025
    Report Date
    January 28, 2026
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    NCX
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL DID NOT RECEIVE THE CATHETER IN COMPLAINT FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND AN INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    B5 (DESCRIBE EVENT OR PROBLEM) WAS UPDATED. D4 (SUSPECT MEDICAL DEVICE, LOT # AND EXPIRATION DATE) WAS UPDATED. D9 (RETURNED TO MANUFACTURER) WAS UPDATED. H4 (DEVICE MANUFACTURE DATE) WAS UPDATED. H6 CODES WERE UPDATED. THE QUATTRO CATHETER WAS RETURNED TO ZOLL WITH ITS SHAFT COMPLETELY CUT 1 INCH AWAY FROM THE MANIFOLD. HOWEVER, BLOOD RESIDUE WAS OBSERVED INSIDE THE BALLOONS. BLOOD INSIDE THE CATHETER BALLOONS IS TYPICALLY INDICATIVE OF A LEAK SOMEWHERE IN THE CATHETER, THUS CONFIRMING THE REPORTED COMPLAINT OF THE SUSPECTED CATHETER LEAK/ BALLOON DAMAGE. SINCE THE CATHETER WAS RETURNED CUT, FUNCTIONAL TESTING COULD NOT BE PERFORMED, AND ZOLL CANNOT PRECISELY DETERMINE THE LEAK LOCATION OR THE TYPE OF LEAK. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE CONDITION IN WHICH THE CATHETER WAS RETURNED. THEREFORE, THE ROOT CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED. IT IS UNLIKELY THAT THE DEFECTIVE CATHETER WAS SHIPPED. DURING MANUFACTURING, ALL CATHETERS ARE 100% INSPECTED FOR LEAKS BY SUBJECTING THEM TO PRESSURE TESTING. ONLY UNITS THAT PASSED ARE MOVED TO THE NEXT PROCESS. HISTORICAL COMPLAINTS WERE REVIEWED FOR INVESTIGATION RESULTS RELATED TO THE REPORTED COMPLAINT, AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINTS REPORTED FOR THE ICY CATHETER WITH LOT NUMBER 199341.

    Description of Event or Problem · 0

    IVTM THERAPY USING THE QUATTRO CATHETER (LOT # 211762) WAS INITIATED. THE CATHETER PLACEMENT SITE AND WHETHER THE INSERTION WAS SMOOTH ARE UNKNOWN. DURING TREATMENT, THE VOLUME OF SALINE IN THE 500-ML BAG WAS OBSERVED TO BE DECREASING. IT IS UNKNOWN AT WHAT STAGE OF TREATMENT THE ISSUE OCCURRED OR WHETHER THE THERMOGARD SYSTEM GENERATED AN AIR TRAP ALARM. CATHETER BALLOON DAMAGE WAS SUSPECTED, AND THE CATHETER WAS REPLACED. TREATMENT CONTINUED AND WAS COMPLETED USING THE SAME THERMOGARD CONSOLE. AN UNDETERMINED AMOUNT OF SALINE WAS SUSPECTED TO HAVE ENTERED THE PATIENT'S BLOODSTREAM. NO PATIENT INJURIES WERE REPORTED.

    Description of Event or Problem · 0

    IVTM THERAPY USING THE QUATTRO CATHETER (LOT # 211221) WAS INITIATED. THE CATHETER PLACEMENT SITE AND WHETHER THE INSERTION WAS SMOOTH ARE UNKNOWN. DURING TREATMENT, THE VOLUME OF SALINE IN THE 500-ML BAG WAS OBSERVED TO BE DECREASING. IT IS UNKNOWN AT WHAT STAGE OF TREATMENT THE ISSUE OCCURRED OR WHETHER THE THERMOGARD SYSTEM GENERATED AN AIR TRAP ALARM. CATHETER BALLOON DAMAGE WAS SUSPECTED, AND THE CATHETER WAS REPLACED. TREATMENT CONTINUED AND WAS COMPLETED USING THE SAME THERMOGARD CONSOLE. AN UNDETERMINED AMOUNT OF SALINE WAS SUSPECTED TO HAVE ENTERED THE PATIENT'S BLOODSTREAM. NO PATIENT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617559 QUATTRO® JAPAN, INTRAVASCULAR HEAT EXCHANGE CATHETER KIT JAPAN CUSTOM LUER INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER NCX ZOLL CIRCULATION, INC. IC-4593 211221

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown