BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM QUATTRO CATHETER

    MDR report key: 10452070 · Received August 25, 2020

    Report

    Report Number
    3010617000-2020-00819
    Event Type
    Malfunction
    Date Received
    August 25, 2020
    Date of Event
    August 4, 2020
    Report Date
    August 25, 2020
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075275
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER ASSOCIATED WITH THIS COMPLAINT WAS DISCARDED BY THE CUSTOMER. SINCE THE DEVICE WAS NOT RETURNED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A PATIENT WAS ADMITTED FOR IVTM THERAPY AFTER CARDIAC ARREST. THE QUATTRO CATHETER (LOT # 140485) WAS SMOOTHLY INSERTED INTO THE PATIENT'S VEIN WITH NO UNUSUAL RESISTANCE NOTED. AN ARTERIAL CATHETER WAS ALSO PLACED FOR MEDICAL REASONS. DURING ASPIRATION, AFTER THE CATHETER WAS FULLY INSERTED, IT WAS NOTED THAT THE CATHETER WAS LEAKING AT THE MEDIAL LUMEN. THE THERMOGARD CONSOLE WAS NOT YET CONNECTED, AND THERAPY HAD NOT YET STARTED WHEN THE ISSUE WAS OBSERVED. THE CATHETER WAS REMOVED WITH NO ISSUES OR RESISTANCE NOTED; HOWEVER, THE MEDIAL LUMEN WAS OBSERVED SEVERELY KINKED. THE CATHETER WAS REPLACED, AND PATIENT TREATMENT WAS COMPLETED SUCCESSFULLY. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911349 ZOLL IVTM QUATTRO CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-4593AE 140485 00849111075275

    Patients

    Seq Age Sex Outcome Treatment
    1