BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23204543 · Received October 2, 2025

    Report

    Report Number
    3010617000-2025-00692
    Event Type
    Malfunction
    Date Received
    October 2, 2025
    Date of Event
    July 30, 2025
    Report Date
    November 7, 2025
    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

    D4 (SUSPECT MEDICAL DEVICE, EXPIRATION DATE) WAS UPDATED. D9 (RETURNED TO MANUFACTURER) WAS UPDATED. H4 (DEVICE MANUFACTURE DATE) WAS UPDATED. H6 CODES WERE UPDATED. THE REPORTED COMPLAINT OF CATHETER LEAK WAS CONFIRMED DURING A VISUAL INSPECTION OF THE RETURNED ICY CATHETER. A CIRCUMFERENTIAL TEAR WAS OBSERVED IN THE MEDIAL BALLOON. THE TEAR WAS LOCATED 2.5 CM AWAY FROM THE PROXIMAL END OF THE MEDIAL BALLOON. THE PROBABLE ROOT CAUSE WAS A LATENT MATERIAL DEFECT. DUE TO THE CONDITION IN WHICH THE CATHETER WAS RECEIVED, THE FUNCTIONAL TEST COULD NOT BE PERFORMED. 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 INFORMATION RELATED TO THE REPORTED COMPLAINT, AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINTS REPORTED FOR THE ICY CATHETER WITH LOT NUMBER 211613.

    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.

    Description of Event or Problem · 0

    IVTM THERAPY WAS INITIATED USING AN ICY CATHETER (LOT # 211613) INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN. IT IS UNKNOWN WHETHER THE INSERTION WAS SMOOTH OR DIFFICULT. DURING THE TREATMENT, BLOOD WAS OBSERVED FLOWING INTO THE START-UP KIT (SUK) TUBING. THE EXACT STAGE AT WHICH THIS OCCURRED IS UNKNOWN, AND NO "AIR TRAP" ALARM WAS REPORTED. THE CUSTOMER IDENTIFIED A CATHETER LEAK AS THE CAUSE, REPLACED BOTH THE CATHETER AND SUK, AND CONTINUED THERAPY. THERE WAS NO MALFUNCTION REPORTED ON THE SUK. NO PATIENT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2434390 ICY® JAPAN, INTRAVASCULAR HEAT EXCHANGE CATHETER KIT JAPAN CUSTOM LUER INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER NCX ZOLL CIRCULATION, INC. 211613

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown