BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT EU APPLAUSE CUSTOM LUER (HEPARIN)

    MDR report key: 23197008 · Received October 1, 2025

    Report

    Report Number
    3010617000-2025-00679
    Event Type
    Malfunction
    Date Received
    October 1, 2025
    Date of Event
    September 1, 2025
    Report Date
    October 1, 2025
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    NCX
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT WAS CONFIRMED BASED ON THE VISUAL INSPECTION OF THE RETURNED ICY CATHETER (LOT #210768). AS RECEIVED, THE CATHETER BALLOONS WERE COMPLETELY DAMAGED. THE CATHETER RETURNED WITHOUT THE DISTAL BALLOON, AND THE MEDIAL BALLOON WAS OBSERVED TO BE DISLODGED ALONG THE CATHETER'S SHAFT. THE PROBABLE ROOT CAUSE OF THE BALLOON DAMAGE IS A BONDING DETACHMENT, RESULTING IN AN INCREASE IN RESISTANCE DURING THE REMOVAL PROCESS. VISUAL INSPECTION OF THE RETURNED CATHETER VERIFIED THAT THE CATHETER'S DISTAL BALLOON WAS MISSING. ALSO, THE MEDIAL BALLOON WAS COMPLETELY DAMAGED, OBSERVED TO BE DISLODGED AND BUNCHED UP, DETACHED FROM THE CATHETER SHAFT DUE TO BONDING DETACHMENT. NO KINK ON THE CATHETER SHAFT AND NO OTHER PHYSICAL DAMAGE WAS OBSERVED. DURING FUNCTIONAL TESTING, ALL INFUSION PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE EXCEPT FOR THE IN/OUT LUER PORTS. THE IN/OUT LUER LUMENS ARE UNABLE TO FLUSH DUE TO DAMAGE TO THE BALLOONS. FURTHER FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE CONDITION IN WHICH THE CATHETER WAS RETURNED. HISTORICAL COMPLAINTS WERE REVIEWED FOR INVESTIGATION RESULTS RELATED TO THE REPORTED COMPLAINT, AND THERE WAS NO SIMILAR HISTORY OF COMPLAINTS REPORTED FOR THE ICY CATHETER WITH LOT NUMBER 210768. THE EVENT OF DEATH WAS SERIOUS BECAUSE IT MET THE CRITERIA FOR SERIOUSNESS (DEATH). USUALLY, CRITICALLY ILL PATIENTS RECEIVE IVTM THERAPY, AND MORTALITY RATE IS HIGH. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS RESPIRATORY FAILURE. BASED ON AVAILABLE INFORMATION, THE PATIENT'S OUTCOME OF DEATH WAS NOT RELATED TO THE DEVICE OR DEVICE DEFICIENCY. THE REPORTED EVENT WAS NOT RELATED TO THE PROCEDURE.

    Description of Event or Problem · 0

    THE PATIENT FAINTED ON THE STREET AND WAS FOUND TO BE IN OUT-OF-HOSPITAL CARDIAC ARREST (OHCA). HYPOTHERMIA TREATMENT BEGAN ON (B)(6) WITH THE ICY CATHETER (LOT #210768) INSERTED VIA THE LEFT FEMORAL VEIN. THE TREATMENT WAS COMPLETED ON (B)(6). THROUGHOUT THE TREATMENT, THE CATHETER BALLOONS SHOWED NO LEAKAGE. AFTER THE TREATMENT WAS COMPLETED, AT 11:29 AM ON (B)(6), THE PHYSICIAN ATTEMPTED TO REMOVE THE CATHETER USING NEGATIVE PRESSURE WITH NORMAL SALINE ASPIRATION. THE PHYSICIAN PERFORMED THE REMOVAL PROCEDURE PER ZOLL INSTRUCTIONS FOR USE (IFU). THE (OUT) LUER OF THE CATHETER WAS CLAMPED BEFORE THE VACUUM FROM THE SYRINGE WAS APPLIED TO THE (IN) LUER. THE CATHETER REMOVAL ATTEMPT WAS UNSUCCESSFUL DUE TO ENCOUNTERING OBVIOUS RESISTANCE. THERE WAS NO OCCLUSION IN THE VEIN, AND THE CATHETER'S BALLOONS WERE DEFLATED WITH A SYRINGE BEFORE THE REMOVAL OF THE CATHETER. ON THE SAME DAY AT 12:30 PM, THE PHYSICIAN ATTEMPTED TO REMOVE THE CATHETER AGAIN WITHOUT USING ANY X-RAY IMAGING BUT FOUND THAT THE CATHETER'S DISTAL BALLOON WAS MISSING. AN ULTRASOUND SCAN WAS PERFORMED, BUT THE MISSING BALLOON COULD NOT BE LOCATED. THE PHYSICIAN SUSPECTED IT WAS STILL IN THE VESSEL. THE CASE WAS DISCUSSED BETWEEN THE CARDIOVASCULAR (CV) AND CARDIOTHORACIC (CVS) PHYSICIANS, AND THEY AGREED TO LEAVE THE ICY CATHETER IN PLACE AND MONITOR THE PATIENT'S CONDITION. ON SEPTEMBER 5TH, CV AND CVS PHYSICIANS DISCUSSED IT AGAIN AND DECIDED TO REMOVE THE ICY CATHETER. THE CATHETER WAS DIRECTLY REMOVED FROM THE PATIENT'S VEIN AT THE PHYSICIANS' JUDGMENT. UPON REMOVAL, THE DISTAL BALLOON WAS STILL MISSING, AND THE SECOND (MEDIAL) BALLOON WAS FOUND TO BE DISLODGED ALONG THE CATHETER'S SHAFT. THE PATIENT HAS BEEN KEPT UNDER OBSERVATION. NO TREATMENT WAS NEEDED FOR THIS EVENT. IT IS UNKNOWN IF THERE WAS ANY ADVERSE IMPACT ON THE PATIENT DUE TO THE REPORTED ISSUE. THE PATIENT PASSED AWAY A FEW DAYS LATER ON (B)(6) 2025. THE PATIENT'S CAUSE OF DEATH WAS RESPIRATORY FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2426623 ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT EU APPLAUSE CUSTOM LUER (HEPARIN) INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER NCX ZOLL CIRCULATION, INC. IC-3893AE 210768

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown