BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITINOL TC ELECTRODE

    MDR report key: 6459354 · Received April 4, 2017

    Report

    Report Number
    3006630150-2017-01300
    Event Type
    Malfunction
    Date Received
    April 4, 2017
    Date of Event
    March 6, 2017
    Report Date
    March 6, 2017
    Manufacturer
    COSMAN MEDICAL
    Product Code
    GXI
    UDI-DI
    813250013054
    PMA / PMN Number
    K050084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED: MODEL#: TCN-10 LOT#: 111516 DESCRIPTION: NITINOL TC ELECTRODE, 100MM ALL ELECTRODES WERE RETURNED AND ANALYZED. THE RESULTS WERE INCONCLUSIVE. THE COMPLAINT COULD NOT BE VERIFIED.

    Additional Manufacturer Narrative · 1

    CORRECTION TO THE INITIAL MDR IN FIELD: SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED: MODEL#: TCN-10, LOT#: 020916, DESCRIPTION: NITINOL TC ELECTRODE, 100MM, QUANTITY: 3 MODEL#: TCN-10, LOT#: 111516, DESCRIPTION: NITINOL TC ELECTRODE, 100MM, QUANTITY: 1 DEVICE ANALYSIS PERFORMED FOR THE 1ST ELECTRODE WITH LOT # 020916 SHOWED THAT EROSION OF THE EPOXY INSIDE THE HUB CAUSED AN INGRESS OF BLOOD AND LIQUID. THE EPOXY WAS FOUND TO HAVE CRACKS, CHIPS MISSING AND DISCOLORATION. THE CRACKS BETWEEN THE EPOXY AND THE INNER WALL OF THE HUB ARE DUE TO THERMAL STRESS ASSOCIATED WITH AUTOCLAVE CYCLES. A DARK RED DISCOLORATION WAS FOUND AND WAS CONFIRMED TO BE DRIED BLOOD. DEVICE ANALYSIS FOR THE 2ND ELECTRODE WITH LOT# 020916 SHOWED THAT EROSION OF THE EPOXY INSIDE THE HUB CAUSED AN INGRESS OF BLOOD AND LIQUID. THE EPOXY WAS FOUND TO HAVE MULTIPLE CHIPS OUT NEAR THE ELECTRODE AND A BROWN DISCOLORATION. THE EPOXY FAILURE WAS DUE TO THERMAL STRESS ASSOCIATED WITH AUTOCLAVE CYCLES. - DEVICE ANALYSIS FOR THE 3RD ELECTRODE WITH LOT# 020916 SHOWED THAT EROSION OF THE EPOXY INSIDE THE HUB CAUSED AN INGRESS OF BLOOD AND LIQUID. THE EPOXY WAS CHIPPED OUT AND SHOWED A DARK RED/BROWN DISCOLORATION AROUND THE SURFACES INSIDE THE HUB. THE DISCOLORATION WAS CONFIRMED TO BE BLOOD. THE EPOXY FAILURE WAS DUE TO THERMAL STRESS ASSOCIATED WITH AUTOCLAVE CYCLES. DEVICE ANALYSIS FOR THE ELECTRODE WITH LOT #111516 SHOWED THAT EROSION OF THE EPOXY INSIDE THE HUB CAUSED AN INGRESS OF BLOOD AND LIQUID. THE EPOXY HAS A CHIP OUT AND A BROWN DISCOLORATION NEAR THE SHAFT DUE TO THERMAL STRESS ASSOCIATED WITH AUTOCLAVE CYCLES.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE GLUE INSIDE THE HUB OF THE ELECTRODE HAS ERODED CAUSING BLOOD AND FLUIDS TO SEEP INSIDE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE GLUE INSIDE THE HUB OF THE ELECTRODE HAS ERODED CAUSING BLOOD AND FLUIDS TO SEEP INSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237895 NITINOL TC ELECTRODE ELECTRODE GXI COSMAN MEDICAL TCN-10 020916 813250013054

    Patients

    Seq Age Sex Outcome Treatment
    1