BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACHOICE IIC CATHETER

    MDR report key: 507179 · Received January 14, 2004

    Report

    Report Number
    507179
    Event Type
    Malfunction
    Date Received
    January 14, 2004
    Date of Event
    October 10, 2003
    Report Date
    January 4, 2004
    Manufacturer
    ETHICON, INC
    Product Code
    MKN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED ON THE BASIS OF WORSENING MENORRHAGIA. PT WANTED CONSERVATIVE SURGICAL MANAGEMENT IN LIEU OF HYSTERECTOMY. WHEN THE FIRST CATHETER WAS UTILIZED, PREPARATIONS WERE MADE, THE PRESSURE WAS STABLIZED, AND THE PRE-TREATMENT HEATING OF THE CATHETER PERFORMED FLAWLESSLY, AND ACCORDING TO MANUFACTURER'S RECOMMENDATIONS. HOWEVER WHEN THE TREATMENT PHASE OF THE CYCLE BEGAN THE WIRE BROKE AND THE PLASTIC TUBING BECAME COILED. GIVEN THE MALFUNCTION THE COMPUTER SHUT DOWN APPROPRIATELY. ANOTHER CATHETER WAS OBTAINED AND PROCESS WAS STARTED ALL OVER AND THE TREATMENT CYCLE WAS ACTIVATED. IN THIS INSTANCE THE CATHETER FAILED TO HEAT AND THE COMPUTER SHUT DOWN, IT SEEMED THESE WERE TWO DISTINCT FAILURES WHICH AT NO TIME DURING THE SURGERY DID RPTR HAVE ANY CONCERN PT'S HEALTH WAS COMPROMISED OR THREATENED IN ANY WAY. THIS IS CALLED UTERINE BALLOON THERAPY BY THERMA CHOICE. PT WAS DISCHARGED THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACHOICE IIC CATHETER BALLOON CATHETER MKN ETHICON, INC R20993 *

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR