BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM QUATTRO CATHETER

    MDR report key: 8880965 · Received August 9, 2019

    Report

    Report Number
    3010617000-2019-00664
    Event Type
    Malfunction
    Date Received
    August 9, 2019
    Date of Event
    July 15, 2019
    Report Date
    August 9, 2019
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED CATHETER ISSUE WAS CONFIRMED. A BONDING LEAK WAS OBSERVED AT THE DISTAL END OF THE MEDIAL 2 BALLOON DURING FUNCTIONAL PRESSURE LEAK TEST. PROBABLE CAUSES FOR THE REPORTED COMPLAINT CAN BE A LATENT MATERIAL DEFECT. VISUAL EXAMINATION OF THE RETURNED CATHETER WAS PERFORMED AND FOUND A KINKED ON THE SHAFT AT THE DISTAL END OF THE MANIFOLD. NO OTHER PHYSICAL DAMAGE WAS OBSERVED. OBSERVED BLOOD RESIDUES ON THE BALLOON. FUNCTIONAL TESTING OF THE RETURNED CATHETER WAS PERFORMED. ALL INFUSION PORTS AND EXTENSION TUBES WERE FLUSHED WITHOUT RESISTANCE. DURING FUNCTIONAL PRESSURE TESTING, THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE. IMMEDIATELY UPON PRESSURIZING THE CATHETER, A BONDING LEAK WAS OBSERVED AT THE DISTAL END OF THE MEDIAL 2 BALLOON. THUS, CONFIRMING CUSTOMER COMPLAINT. 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 93761.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT THERAPEUTIC IVTM TREATMENT FOR THERAPEUTIC HYPOTHERMIA. THE QUATTRO CATHETER WAS INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN WITHOUT ISSUE. AFTER THREE HOURS OF IVTM THERAPY, THE THERMOGARD CONSOLE DISPLAYED AN AIRTRAP ALARM. FOLLOWING THIS, THE QUATTRO CATHETER AND THE START-UP KIT (SUK) WERE REPLACED AND IVTM THERAPY WAS RESUMED WITH NO FURTHER ISSUE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672735 ZOLL IVTM QUATTRO CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-4593AE 93761 00849111075275

    Patients

    Seq Age Sex Outcome Treatment
    1