BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT APPLAUSE CUSTOM LUER

    MDR report key: 21827652 · Received April 11, 2025

    Report

    Report Number
    3010617000-2025-00245
    Event Type
    Malfunction
    Date Received
    April 11, 2025
    Date of Event
    February 22, 2025
    Report Date
    May 14, 2025
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    NCX
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL HAS NOT RECEIVED THE ICY CATHETER FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF AND WHEN THE PRODUCT IS RETURNED, AND THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S COMPLAINT OF A CATHETER BALLOON LEAK WAS CONFIRMED WHILE FLUSHING THE RETURNED ICY CATHETER (LOT #191568) DURING THE DECONTAMINATION PROCESS. DURING THE IN/OUT LUMEN FLUSHING, A LEAK WAS OBSERVED FROM THE PROXIMAL END OF THE DISTAL BALLOON DUE TO A TEAR IN THE BALLOON. DURING FUNCTIONAL TESTING, ALL INFUSION PORTS AND LUMEN WERE FLUSHED WITHOUT RESISTANCE. UPON FLUSHING THE IN/OUT LUMEN, A LEAK WAS OBSERVED FROM THE PROXIMAL END OF THE DISTAL BALLOON. FURTHER INSPECTION OF THE CATHETER UNDER A MICROSCOPE SHOWED A BALLOON TEAR LOCATED 1 CM AWAY FROM THE PROXIMAL END OF THE DISTAL BALLOON, CONFIRMING THE REPORTED COMPLAINT. PRESSURIZED FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE LEAK DISCOVERED DURING THE IN/OUT LUMEN TEST. HISTORICAL COMPLAINTS WERE REVIEWED FOR AN INVESTIGATION RELATED TO THE REPORTED COMPLAINT, AND ONE SIMILAR COMPLAINT WAS REPORTED FOR THE ICY CATHETER WITH LOT #191568. (B)(6) WAS REPORTED ON MARCH 03, 2025, AND A BALLOON TEAR WAS CONFIRMED AT THE PROXIMAL END OF THE DISTAL BALLOON.

    Description of Event or Problem · 0

    UPON OPENING THE ICY CATHETER KIT (LOT #191568), THE PHYSICIAN TESTED THE CATHETER BEFORE INSERTING IT FOR IVTM THERAPY. DURING THE TEST, A LEAK WAS FOUND IN THE CATHETER'S BALLOON. CONSEQUENTLY, A NEW CATHETER WAS UTILIZED TO INITIATE THE TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2348383 ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT APPLAUSE CUSTOM LUER INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER NCX ZOLL CIRCULATION, INC. IC-3893CO 191568

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown