BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM QUATTRO CATHETER

    MDR report key: 9417460 · Received December 5, 2019

    Report

    Report Number
    3010617000-2019-01079
    Event Type
    Malfunction
    Date Received
    December 5, 2019
    Date of Event
    November 8, 2019
    Report Date
    December 5, 2019
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075138
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT OF LEAK ON THE QUATTRO CATHETER (LOT # 96104) WAS CONFIRMED DURING FUNCTIONAL TESTING OF THE RETURNED CATHETER. A BONDING LEAK WAS OBSERVED AT PROXIMAL END OF MEDIAL 1 BALLOON. THE PROBABLE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD BE DUE TO A LATENT DEFECT AT THE BOND. VISUAL EXAMINATION OF THE RETURNED CATHETER WAS PERFORMED AND FOUND NO PHYSICAL DAMAGE TO THE CATHETER. DRIED BLOOD RESIDUE WAS OBSERVED ON THE CATHETER'S BALLOONS AND IN/OUT LUERED TUBINGS. DURING FUNCTIONAL TESTING OF THE RETURNED CATHETER, ALL INFUSION PORTS AND EXTENSION TUBES WERE FLUSHED WITHOUT RESISTANCE. THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE. IMMEDIATELY UPON PRESSURIZING THE CATHETER, A BOND LEAK WAS OBSERVED AT THE PROXIMAL END OF THE MEDIAL 1 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 NEXT PROCESS. HISTORICAL COMPLAINTS WERE REVIEWED FOR INFORMATION RELATED TO THE REPORTED COMPLAINT, AND THERE WAS NO PREVIOUS COMPLAINT REPORTED FOR QUATTRO CATHETER WITH LOT NUMBER 96104.

    Description of Event or Problem · 1

    DURING PATIENT IVTM THERAPY, THE THERMOGARD IVTM SYSTEM ALARMED AND DISPLAYED AN "AIR TRAP" MESSAGE. THE SALINE BAG WAS OBSERVED ALMOST EMPTY. CUSTOMER DISCONNECTED THE QUATTRO CATHETER (LOT # 96104) FROM THE START-UP KIT (SUK), AND BLOOD TINGE WAS OBSERVED IN THE ORANGE LUER. AS PER CUSTOMER, THE PATIENT WAS ON SEVERAL BLOOD THINNER MEDICATIONS, AND THERE WAS SOME BLOOD OOZE AT THE INSERTION SITE. COMPROMISED CATHETER BALLOON WAS SUSPECTED, AND IT WAS SUGGESTED TO THE CUSTOMER TO EITHER OVER-WIRE EXCHANGE OR REPLACE THE CATHETER. HOWEVER, THE PHYSICIAN DECIDED NOT TO PLACE A NEW QUATTRO CATHETER, BUT RATHER, EXCHANGE THE QUATTRO FOR A STANDARD CVC AND CONTINUE THE THERAPY USING ALTERNATIVE METHOD. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT WAS REPORTED. NO DEVICE MALFUNCTION ON THE IN-USE TGXP THERMOGARD CONSOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211571 ZOLL IVTM QUATTRO CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-4593 96104 00849111075138

    Patients

    Seq Age Sex Outcome Treatment
    1