BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 14097284 · Received April 13, 2022

    Report

    Report Number
    3010617000-2022-00382
    Event Type
    Malfunction
    Date Received
    April 13, 2022
    Date of Event
    March 21, 2022
    Report Date
    April 12, 2022
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075251
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF A CUSTOMER SUSPECTING A BLOCKAGE INSIDE THE ICY CATHETER WAS CONFIRMED DURING VISUAL INSPECTION. A KINK ON THE SHAFT AT 7.5CM FROM THE CATHETER TIP WAS OBSERVED IN WHICH LIKELY CAUSE THE SUK NOT TO FILL AND THE RED FLOW WHEEL TO NOT ROTATE. THE EXACT TIMING AND CAUSE OF KINKING OF THE CATHETER CANNOT BE DETERMINED. THE PROBABLE ROOT CAUSE OF THE KINKED ICY CATHETER WAS LIKELY DUE TO USER ERROR. UPON VISUAL INSPECTION, OBSERVED THE CATHETER SHAFT WAS KINKED AT 7.5CM FROM THE CATHETER TIP, THUS CONFIRMING THE REPORTED COMPLAINT. NO OTHER PHYSICAL DAMAGE WAS OBSERVED. NOTICED BLOOD RESIDUE ON THE BALLOONS AND IN THE MEDIAL LUERED TUBING. ALL LUMENS WERE FLUSHED WITHOUT RESISTANCE. PRESSURE LEAK TEST WAS PERFORMED, THE ICY CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE, THE BALLOONS FULLY INFLATED WHEN PRESSURIZED UP TO 100 PSI WITHOUT ANY ISSUES. NO LEAK WAS FOUND DURING TESTING. A KNOWN-GOOD GUIDEWIRE WAS INSERTED THROUGH THE CENTRAL LUMEN OF THE CATHETER STARTING AT THE DISTAL TIP, THE GUIDE WIRE GETS STUCK AT 7.5CM FROM THE CATHETER TIP DUE TO THE KINK ON THE SHAFT. HISTORICAL COMPLAINTS WERE REVIEWED FOR INFORMATION RELATED TO THE REPORTED COMPLAINT AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINT REPORTED FOR A CATHETER WITH LOT NUMBER 163479.

    Description of Event or Problem · 0

    DURING IVTM THERAPY AND AFTER 24 HOURS INTO TREATMENT, CUSTOMER NOTICED THAT THE RED FLOW INDICATOR ON THE START-UP KIT (SUK) WAS NOT ROTATING. THE CUSTOMER FOUND NO LEAKS OR DAMAGE ON THE SUK. THE CUSTOMER DETACHED THE SUK FROM THE ICY CATHETER (LOT #163479) AND THE SUK FLOW INDICATOR FUNCTIONED PROPERLY WITHOUT ANY ISSUE. THE CUSTOMER SEEMS TO SUSPECT A BLOCKAGE INSIDE THE ICY CATHETER. PER REPORTER, THE CATHETER INSERTION INTO THE PATIENT'S FEMORAL VEIN WAS SMOOTH. THE THERMOGARD CONSOLE DID NOT GENERATE AN ALARM. THERE WAS NO OTHER TEMPERATURE MANAGEMENT OR RELATIVE PROCEDURES PERFORMED ON THE PATIENT. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810895 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-3893AE 163479 00849111075251

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown