BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 14191176 · Received April 24, 2022

    Report

    Report Number
    3010617000-2022-00421
    Event Type
    Malfunction
    Date Received
    April 24, 2022
    Date of Event
    March 30, 2022
    Report Date
    April 24, 2022
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075527
    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 CUSTOMER REPORTED ISSUE OF DIFFICULTY TO ADVANCE THE CATHETER INTO THE PATIENT WAS NOT CONFIRMED DURING THE ICY CATHETER (LOT # 172325) INSPECTION. THE GOOD-KNOWN GUIDEWIRE WAS DRAWN COMPLETELY THROUGH THE CATHETER DISTAL TIP, NO PROBLEM WAS OBSERVED. THE GUIDEWIRE PASSED THROUGH THE CATHETER WITHOUT ANY RESISTANCE. THE CATHETER WORKED AS INTENDED. A VISUAL EXAMINATION OF THE RETURNED CATHETER WAS PERFORMED. NO PHYSICAL DAMAGE TO THE CATHETER WAS FOUND. THERE WAS NO KINK OBSERVED ON THE CATHETER. NOTED DRIED BLOOD RESIDUE ON THE BALLOONS AND LUERED TUBINGS. FUNCTIONAL TESTING OF THE RETURNED CATHETER WAS PERFORMED. ALL INFUSION PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE. THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE, AND THE BALLOONS WERE FULLY INFLATED WHEN PRESSURIZED UP TO 100 PSI WITHOUT ANY ISSUES. THE BALLOONS DID NOT LEAK DURING INFLATION AND DEFLATION. NO LEAK WAS OBSERVED.

    Description of Event or Problem · 0

    DURING THE ICY CATHETER (LOT # 172325) PLACEMENT FOR IVTM THERAPY, THE CUSTOMER EXPERIENCED DIFFICULTY WHILE ADVANCING THE CATHETER OVER THE GUIDEWIRE. THE USER USED A NEW GUIDEWIRE AND THE SECOND CATHETER WAS PLACED SUCCESSFULLY TO CONTINUE THE THERAPY. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171289 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-3893 172325 00849111075527

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown