BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM QUATTRO CATHETER

    MDR report key: 17549494 · Received August 15, 2023

    Report

    Report Number
    3010617000-2023-00695
    Event Type
    Malfunction
    Date Received
    August 15, 2023
    Date of Event
    July 25, 2023
    Report Date
    August 15, 2023
    Manufacturer
    ZOLL CIRCULATION INC
    Product Code
    NCX
    UDI-DI
    00849111075138
    PMA / PMN Number
    K072234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF A LEAK IN THE QUATTRO CATHETER (LOT 183530) WAS CONFIRMED DURING FUNCTIONAL TESTING. A PINHOLE LEAK WAS OBSERVED AT THE PROXIMAL END OF THE DISTAL BALLOON DURING THE FUNCTIONAL PRESSURE LEAK TEST. THE PROBABLE ROOT CAUSE OF THE PINHOLE LEAK WAS A LATENT MATERIAL DEFECT. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED, AND NO PHYSICAL DAMAGE WAS FOUND ON THE CATHETER. BLOOD RESIDUE IN THE BALLOONS AND LUERED TUBINGS WAS ALSO OBSERVED. FUNCTIONAL LEAK TEST OF THE RETURNED CATHETER WAS PERFORMED, AND ALL INFUSION PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE. DURING THE FUNCTIONAL PRESSURE LEAK TEST, THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE. UPON PRESSURIZING THE CATHETER, A PINHOLE LEAK WAS OBSERVED AT THE PROXIMAL END OF THE DISTAL BALLOON (2 CM AWAY FROM THE PROXIMAL END); 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 HISTORY OF COMPLAINTS REPORTED FOR THE QUATTRO CATHETER WITH LOT 183530.

    Description of Event or Problem · 0

    IVTM THERAPY WAS STARTED FOR A PATIENT AFTER THE QUATTRO CATHETER (LOT 183530) WAS PLACED ON (B)(6) 23. THE CATHETER WAS INSERTED SMOOTHLY ON THE FIRST ATTEMPT. DURING THE NORMOTHERMIA STAGE OF THERAPY, PINK BLOOD TINGE WAS NOTED IN TUBING AND SALINE BAG. THE DWELL TIME OF THE CATHETER IS UNKNOWN. THE SITE WAS USING CATHETER FOR CENTRAL LINE. IVTM THERAPY WAS DISCONTINUED, AND THE CATHETER WAS REMOVED. THERAPY WAS PERFORMED FOR 12-16 HOURS BEFORE IT WAS DISCONTINUED. THE CUSTOMER BELIEVES THE LEAK WAS LOCATED AT THE SECOND MOST PROXIMAL BALLOON. NO IMPACT OR CONSEQUENCE ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963568 ZOLL IVTM QUATTRO CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION INC IC-4593 183530 00849111075138

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown