BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT APPLAUSE CUSTOM LUER

    MDR report key: 21692356 · Received March 25, 2025

    Report

    Report Number
    3010617000-2025-00215
    Event Type
    Malfunction
    Date Received
    March 25, 2025
    Date of Event
    January 8, 2025
    Report Date
    May 28, 2025
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    NCX
    UDI-DI
    00849111075527
    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 YET RECEIVED THE CATHETER IN COMPLAINT FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    D4 (SUSPECT MEDICAL DEVICE, EXPIRATION DATE) WAS UPDATED. D9 (RETURNED TO MANUFACTURER) WAS UPDATED. H4 (DEVICE MANUFACTURE DATE) WAS UPDATED. THE CUSTOMER'S COMPLAINT OF A CATHETER'S 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 1.5 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 INVESTIGATION RESULTS RELATED TO THE REPORTED COMPLAINT, AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINTS REPORTED FOR THE ICY CATHETER WITH LOT NUMBER 191568.

    Additional Manufacturer Narrative · 0

    H6 CODE (TYPE OF INVESTIGATION) WAS CORRECTED FROM 4109 TO 4110.

    Description of Event or Problem · 0

    WHEN THE PHYSICIAN OPENED THE ICY CATHETER KIT (LOT # 191568) AND TESTED THE CATHETER PRIOR TO INSERTION FOR AN IVTM THERAY, A LEAK WAS DETECTED IN THE CATHETER'S BALLOON. A NEW CATHETER WAS USED TO START THE TREATMENT. NO FURTHER INFORMATION WAS PROVIDED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1695665 ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT APPLAUSE CUSTOM LUER INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER NCX ZOLL CIRCULATION, INC. IC-3893CO 191568 00849111075527

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown