BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM COOL LINE CATHETER

    MDR report key: 14571080 · Received June 2, 2022

    Report

    Report Number
    3010617000-2022-00538
    Event Type
    Malfunction
    Date Received
    June 2, 2022
    Date of Event
    May 2, 2022
    Report Date
    June 30, 2022
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    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

    ZOLL HAS RECEIVED THE COOL LINE CATHETER (LOT #160313) FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IN H4 (DEVICE MANUFACTURE DATE). THE CUSTOMER'S COMPLAINT OF "A LEAK FROM THE COOL LINE CATHETER (LOT #160313)" WAS CONFIRMED DURING THE FUNCTIONAL TESTING. DURING THE FUNCTIONAL PRESSURE LEAK TEST, A LEAK WAS OBSERVED FROM THE MIDDLE OF THE DISTAL BALLOON. THE ROOT CAUSE OF THE LEAK WAS A CUT AT THE MIDDLE OF THE DISTAL BALLOON. UNDER THE MICROSCOPE, THE CUT APPEARED TO BE A SMALL, STRAIGHT, AND CLEAN LINE, MEASURING 0.98 MM. THE ROOT CAUSE FOR THE CUT WAS A LATENT MATERIAL DEFECT. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED. OBSERVED THE CATHETER SHAFT WAS KINKED AT 15.5 CM OF SHAFT MARKER. THE EXACT TIMING AND CAUSE OF THE KINK ON THE CATHETER CANNOT BE DETERMINED; HOWEVER, IMPROPER HANDLING OF THE CATHETER CANNOT BE RULED OUT. NO OTHER PHYSICAL DAMAGE WAS OBSERVED ON THE CATHETER. A FUNCTIONAL LEAK TEST WAS PERFORMED, AND ALL INFUSION PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE. DURING THE FUNCTIONAL PRESSURE LEAK TEST, THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE. UPON PRESSURIZING THE CATHETER, A LEAK WAS OBSERVED AT MIDDLE OF DISTAL BALLOON; THUS, CONFIRMING THE REPORTED COMPLAINT. IT IS UNLIKELY THAT THE DEFECTIVE CATHETER WAS SHIPPED. DURING MANUFACTURING, ALL CATHETERS ARE 100% INSPECTED FOR LEAKS BY SUBJECTING THEM TO PRESSURE TESTING. ONLY UNITS THAT PASSED ARE MOVED TO THE FOLLOWING PROCESS. HISTORICAL COMPLAINTS WERE REVIEWED FOR INFORMATION RELATED TO THE REPORTED COMPLAINT, AND NO SIMILAR COMPLAINT WAS REPORTED FOR THE COOL LINE CATHETER WITH LOT NUMBER 160313.

    Description of Event or Problem · 0

    ON (B)(6), 2022, AN IVTM THERAPY WAS INITIATED FOR A SUBARACHNOID HEMORRHAGE (SAH) PATIENT USING A COOL LINE CATHETER (LOT #160313) AND START-UP KIT (SUK) (LOT #165863). DURING THE COOLING PHASE ON (B)(6), 2022, THE THERMOGARD XP IVTM SYSTEM GENERATED AN "AIR TRAP WARNING" ALARM THREE TIMES. THE CUSTOMER NOTED THAT THE SALINE LEVEL IN THE SALINE BAG WAS NOT DECREASED AND COULD NOT FIND THE CAUSE FOR THE ALARM. THE FOLLOWING DAY ON (B)(6), 2022, THE THERMOGARD XP IVTM SYSTEM AGAIN GENERATED AN "AIR TRAP WARNING" ALARM. THE CUSTOMER PUT THE THERMOGARD SYSTEM IN A STAND-BY MODE TO CONFIRM THAT THE PATIENT'S TEMPERATURE WAS NORMAL (NO FEVER) AND ENDED THE TEMPERATURE MANAGEMENT THERAPY. THE CUSTOMER REMOVED THE CATHETER, AND A LEAK FROM THE BALLOON WAS CONFIRMED. THE CUSTOMER REPORTED NO DEVICE MALFUNCTION FOR THE SUK AND THE THERMOGARD SYSTEM. THE THERMOGARD SYSTEM WAS PLACED BACK IN SERVICE FOR CLINICAL USE. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184842 ZOLL IVTM COOL LINE CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION CL-2295 160313

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown