BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 6201211 · Received December 22, 2016

    Report

    Report Number
    3010617000-2016-00938
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    November 26, 2016
    Report Date
    January 27, 2017
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075084
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED COMPLAINT OF BLOOD NOTED INSIDE THE ZOLL ICY CATHETER AND THE SALINE BAG HAD RUN DRY WAS CONFIRMED DURING THE FUNCTIONAL TESTING. A PINHOLE LEAK WAS NOTED AT THE DISTAL BALLOON; HOWEVER THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. DURING FUNCTIONAL TESTING, THE RETURNED CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE AND PRESSURE WAS INCREASED UP TO 100PSI. IMMEDIATELY UPON PRESSURIZATION, A PINHOLE LEAK WAS FOUND AT THE DISTAL BALLOON. THE POTENTIAL CAUSE OF THE PINHOLE LEAK IS LIKELY TO BE LATENT DEFECT (E.G., A MICROSCOPIC GEL PARTICLE) IN THE BALLOON THAT EVENTUALLY LEADS TO A PINHOLE. ALL BALLOONS GO THROUGH A THOROUGH INSPECTION AND TEST PRIOR TO AND DURING CATHETER ASSEMBLY PROCESS TO ENSURE VISUAL, STRUCTURAL AND FUNCTIONAL INTEGRITY. THIS INCLUDES DESTRUCTIVE TESTING TO VERIFY BURST STRENGTH. IN ADDITION, DURING MANUFACTURING, ALL ICY CATHETER ARE 100% INSPECTED FOR LEAKS. IN ADDITION, EXTENSION TUBING IS ALSO 100% TESTED FOR LEAKS. ONLY UNITS THAT PASS THE TESTING ARE MOVED TO THE NEXT PROCESS. A VISUAL INSPECTION OF THE RETUNED CATHETER WAS PERFORMED. THE CATHETER WAS RECEIVED WITH VERY MINIMUM DRIED UP BLOOD ON THE BALLOONS, SHAFT, LUERED TUBINGS AND INFUSION PORTS. HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT AND THERE WAS NO PREVIOUS HISTORY OF RELATED COMPLAINTS FOR ICY CATHETER LOT # 67322.

    Additional Manufacturer Narrative · 1

    THE ZOLL CATHETER IN COMPLAINT WAS RETURNED TO ZOLL ON 12/21/2014 FOR INVESTIGATION. HOWEVER, INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED WHEN INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT USE, BLOOD WAS NOTED INSIDE ZOLL ICY CATHETER AND THE SALINE BAG HAD RUN DRY. THE ICY CATHETER WAS REMOVED AND REPLACED TO CONTINUE THE TREATMENT. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE REPORTER FOR ADDITIONAL INFORMATION; HOWEVER, WERE UNSUCCESSFUL. NO FURTHER INFORMATION WAS PROVIDED. NO KNOWN PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848097 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-3893 00849111075084

    Patients

    Seq Age Sex Outcome Treatment
    1