BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM QUATTRO CATHETER

    MDR report key: 11457687 · Received March 10, 2021

    Report

    Report Number
    3010617000-2021-00193
    Event Type
    Malfunction
    Date Received
    March 10, 2021
    Date of Event
    February 13, 2021
    Report Date
    March 10, 2021
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT ABOUT THE QUATTRO CATHETER (LOT # 142198) LEAK WAS CONFIRMED. DURING THE FUNCTIONAL LEAK TEST, A PINHOLE LEAK WAS OBSERVED AT DISTAL END OF MEDIAL 1 BALLOON. THE PROBABLE ROOT CAUSE OF THE PINHOLE LEAK WAS DUE TO A LATENT MATERIAL DEFECT. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED AND NO PHYSICAL DAMAGE WAS OBSERVED. FUNCTIONAL TESTING OF THE RETURNED CATHETER WAS PERFORMED. ALL INFUSION PORTS AND EXTENSION TUBES WERE FLUSHED WITHOUT RESISTANCE. THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE FOR ONE MINUTE, THE BALLOONS WERE FULLY INFLATED WHEN PRESSURIZED UP TO 100 PSI. IMMEDIATELY UPON PRESSURIZING THE CATHETER, A PINHOLE LEAK WAS OBSERVED AT DISTAL END OF MEDIAL 1 BALLOON. THEREFORE, THE REPORTED COMPLAINT WAS CONFIRMED. 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 CATHETER LEAK AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINTS REPORTED FOR QUATTRO CATHETER WITH LOT NUMBER 142198.

    Description of Event or Problem · 1

    AFTER 4 HOURS AND 20 MINS OF IVTM THERAPY, THE SALINE BAG WAS OBSERVED TO DECREASE IN VOLUME, NO LEAK WAS OBSERVED ON THE SUK AND THE THERMOGARD CONSOLE GENERATED AN "AIR TRAP" ALARM DURING LEAK CHECK. AFTER 10 MINUTES, THE PHYSICIAN SUSPECTED A QUATTRO CATHETER (LOT# 142198) LEAK AND THE IVTM THERAPY WAS DISCONTINUED. ADJUNCT THERAPY WAS USED TO CONTINUE TREATMENT. NO CONSEQUENCES OR IMPACT TO PATIENT. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR 3010617000-2021-00240 FOR THERMOGARD CONSOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348959 ZOLL IVTM QUATTRO CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION 8700-0783-03 142198

    Patients

    Seq Age Sex Outcome Treatment
    1