BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT EU APPLAUSE CUSTOM

    MDR report key: 22822203 · Received August 15, 2025

    Report

    Report Number
    3010617000-2025-00550
    Event Type
    Injury
    Date Received
    August 15, 2025
    Date of Event
    June 29, 2025
    Report Date
    September 19, 2025
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    NCX
    UDI-DI
    00849111075251
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL HAS NOT RECEIVED THE ICY CATHETER FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE PRODUCT IS RETURNED AND THE INVESTIGATION HAS BEEN COMPLETED. THE EVENT WAS ASSESSED AS NOT SERIOUS BECAUSE IT DOES NOT MEET THE CRITERIA FOR SERIOUSNESS. BASED ON AVAILABLE INFORMATION, THE EVENT OF "SWELLING AT THE INSERTION SITE" WAS CAUSALLY RELATED TO THE ZOLL CATHETER DUE TO RELEVANT TIMING AND LOCATION AND NO OTHER OBVIOUS CAUSE FOR SUCH EVENT. SWELLING SUBCUTANEOUS TISSUE AROUND A CATHETER IS AN ANTICIPATED EVENT AND COULD POTENTIALLY OCCUR WITH USAGE OF ANY CATHETER. THE EVENT OF "SWELLING AT THE INSERTION SITE" WAS CAUSALLY RELATED TO THE DEVICE AND PROCEDURE.

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF THE CATHETER LEAK WAS NOT CONFIRMED DURING VISUAL AND FUNCTIONAL TESTING OF THE RETURNED ICY CATHETER (LOT # 210055). NO ISSUES OR DISCREPANCIES WERE FOUND. NO LEAK OR MALFUNCTION WAS OBSERVED DURING TESTING, AND THE CATHETER FUNCTIONED AS INTENDED. DURING THE FUNCTIONAL PRESSURE LEAK TEST, ALL INFUSION PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE AND FUNCTIONED AS INTENDED. DURING THE FUNCTIONAL PRESSURE LEAK TEST, THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE, AND THE BALLOONS WERE FULLY INFLATED WHEN PRESSURIZED UP TO 100 PSI. NO LEAKS OR ISSUES WERE FOUND. THE BALLOON DID NOT LEAK DURING TESTING. NO LEAK WAS FOUND ON THE CATHETER SHAFT, MANIFOLD, OR IN ANY LUER CONNECTIONS. IN ADDITION, THE RETURNED CATHETER WAS CONNECTED TO A KNOWN-GOOD SUK AND RAN ON A PERISTALTIC PUMP FOR 10 MINUTES AT A HIGH-SPEED RATE. NO LEAK WAS OBSERVED, AND THE CATHETER FUNCTIONED AS INTENDED. DURING FURTHER FUNCTIONAL TESTING, THE RETURNED CATHETER WAS CONNECTED TO A KNOWN-GOOD SUK AND RAN ON THE THERMOGARD CONSOLE SYSTEM, RUNNING IN THE MAX WARMING MODE WITH A TARGET TEMPERATURE AT 37°C FOR 60 MINUTES AND RUNNING IN THE MAX COOLING MODE WITH A TARGET TEMPERATURE AT 35°C FOR 60 MINUTES. NO LEAK WAS OBSERVED ON THE CATHETER. THE BALLOONS WERE PROPERLY WARMED DURING THE WARMING MODE AND COOLED DURING THE COOLING MODE. THE RED PINWHEEL OF THE SUK WAS SPINNING AS NORMAL. NO PROBLEM WAS FOUND, AND THE CATHETER FUNCTIONED AS INTENDED.

    Description of Event or Problem · 0

    DURING IVTM THERAPY, APPROXIMATELY 50 HOURS INTO HYPOTHERMIA MANAGEMENT, A SALINE LEAK WAS OBSERVED AT THE VASCULAR ACCESS (PUNCTURE) SITE OF THE ICY CATHETER (LOT # 210055). UPON EVALUATION, THE ATTENDING PHYSICIAN IDENTIFIED THAT THE CATHETER HAD BECOME DISLODGED, HAVING MIGRATED OUTWARD FROM ITS ORIGINAL PLACEMENT. ACCORDING TO THE REPORTER, THE PATIENT WAS NOT MOVED OR TRANSPORTED BEFORE THE REPORTED ISSUE, AND THE CATHETER WAS SUTURED AND SECURED WITH CATHETER WINGS. THE SALINE LEAK, ESTIMATED TO BE AT A RATE OF APPROXIMATELY ONE DROP EVERY TWO SECONDS, WAS DETERMINED TO BE ORIGINATING FROM THE INSERTION SITE. THERE WAS NO SUSPECTED SALINE INFUSION INTO THE PATIENT'S BLOODSTREAM. AFTER DISCONTINUING THE INFUSION VIA THE PROXIMAL INFUSION PORT, THE LEAKAGE STOPPED IMMEDIATELY. NOTABLY, THE PATIENT'S RIGHT LEG (CATHETER INSERTION) WAS SWOLLEN WHEN COMPARED WITH THE LEFT LEG, AND THE CATHETER INSERTION SITE WAS SLIGHTLY RED AND SWOLLEN. AFTER INSPECTION, THE PHYSICIAN DECIDED TO REMOVE THE EXISTING CATHETER AND PLACE THE NEW ONE IN THE LEFT FEMORAL VEIN. AFTER REPLACING THE CATHETER, THE SWELLING GRADUALLY SUBSIDED. THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2390630 ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT EU APPLAUSE CUSTOM INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER NCX ZOLL CIRCULATION, INC. IC-3893AE 210055 00849111075251

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown