BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM QUATTRO CATHETER

    MDR report key: 12493110 · Received September 18, 2021

    Report

    Report Number
    3010617000-2021-00846
    Event Type
    Malfunction
    Date Received
    September 18, 2021
    Date of Event
    August 25, 2021
    Report Date
    November 13, 2021
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075084
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF THE QUATTRO CATHETER (LOT # 163688) LEAK WAS CONFIRMED. THE LEAK WAS OBSERVED AT THE MIDDLE OF THE MEDIAL 2 BALLOON DURING THE FUNCTIONAL LEAK TEST. THE ROOT CAUSE FOR THE REPORTED COMPLAINT RESULTED FROM A CIRCUMFERENTIAL TEAR, WHICH WAS POSSIBLY CAUSED BY A LATENT MATERIAL DEFECT. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED. DRIED BLOOD RESIDUE WAS OBSERVED ON THE CATHETER'S BALLOONS AND IN/OUT LUERED TUBINGS; THIS TYPICALLY IS INDICATIVE OF A LEAK IN THE CATHETER. OBSERVED THE CATHETER SHAFT WAS KINKED AT 7.5 IN AWAY FROM THE CATHETER TIP. MOST LIKELY, THAT THE CATHETER WAS DAMAGED WHEN IT WAS FOLDED AND PLACED INTO THE BAG FOR SHIPPING. DURING FUNCTIONAL TESTING, ALL INFUSION PORTS AND EXTENSION TUBES WERE FLUSHED WITHOUT RESISTANCE. THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE. UPON PRESSURIZING THE CATHETER, A LEAK WAS OBSERVED AT THE MIDDLE OF THE MEDIAL 2 BALLOON, THUS CONFIRMING THE REPORTED COMPLAINT. WHEN OBSERVED UNDER THE MICROSCOPE, A CIRCUMFERENTIAL TEAR WAS NOTED ON THE BALLOON. 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 NEXT PROCESS. HISTORICAL COMPLAINTS WERE REVIEWED FOR INFORMATION RELATED TO THE REPORTED COMPLAINT, AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINT REPORTED FOR THE QUATTRO CATHETER WITH LOT NUMBER 163688.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT DURING IVTM THERAPY THE QUATTRO CATHETER (LOT # 163688) ) WAS OBSERVED LEAKING SALINE FLUID. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

    Additional Manufacturer Narrative · 1

    ZOLL HAS NOT RECEIVED THE ICY CATHETER FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING IVTM THERAPY THE ICY CATHETER (LOT # UNKNOWN) WAS OBSERVED LEAKING SALINE FLUID. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390712 ZOLL IVTM QUATTRO CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-4593 163688 00849111075084

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown