BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL LINE® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT JAPAN, FINAL PKGED KIT NE

    MDR report key: 24820635 · Received April 8, 2026

    Report

    Report Number
    3010617000-2026-00212
    Event Type
    Malfunction
    Date Received
    April 8, 2026
    Date of Event
    March 17, 2026
    Report Date
    April 23, 2026
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    NCX
    UDI-DI
    00849111075176
    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

    THE REPORTED COMPLAINT OF A LEAK FROM THE COOL LINE CATHETER (LOT 212939) WAS CONFIRMED DURING FUNCTIONAL TESTING. A PINHOLE LEAK WAS OBSERVED FROM THE DISTAL END OF DISTAL BALLOON DURING THE FUNCTIONAL PRESSURE LEAK TEST. THE PROBABLE ROOT CAUSE OF THE PINHOLE LEAK WAS A LATENT MATERIAL DEFECT. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED. NO PHYSICAL DAMAGE WAS OBSERVED ON THE CATHETER. BLOOD RESIDUE WAS OBSERVED IN THE LUERED TUBINGS. FUNCTIONAL LEAK TEST OF THE RETURNED CATHETER WAS PERFORMED. ALL INFUSION PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE. 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. UPON PRESSURIZING THE CATHETER, A PINHOLE LEAK WAS OBSERVED FROM THE DISTAL END OF DISTAL BALLOON, CONFIRMING THE REPORTED COMPLAINT. HISTORICAL COMPLAINTS WERE REVIEWED FOR INFORMATION RELATED TO THE REPORTED COMPLAINT, AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINTS REPORTED FOR THE COOL LINE CATHETER WITH LOT NUMBER 212939.

    Additional Manufacturer Narrative · 0

    THE CATHETER IN THE COMPLAINT HAS NOT BEEN RETURNED FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    ON 3/17/2026, SIX DAYS AFTER INITIATING IVTM THERAPY USING THE COOL LINE CATHETER (LOT 212939) FOR A PATIENT WITH A HEAD INJURY, DURING COOLING, THE AIR TRAP ALARM SOUNDED, AND THE SALINE IN THE SALINE BAG WAS EMPTY. TEMPERATURE MANAGEMENT WAS TERMINATED AT THAT POINT. THE ALARM ON THE CONSOLE WAS CLEARED, AND THE CONSOLE IS BACK IN SERVICE. NO INJURIES TO THE PATIENT HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312986 COOL LINE® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT JAPAN, FINAL PKGED KIT NE INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER NCX ZOLL CIRCULATION, INC CL-2295 212939 00849111075176

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown