BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACHOICE

    MDR report key: 1141060 · Received August 29, 2008

    Report

    Report Number
    2210968-2008-00746
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    July 29, 2008
    Report Date
    July 29, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    MKN
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION CODE: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFO DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. THIS IS ONE OF TWO MEDWATCHES SENT AS TWO EVENTS OCCURRED. SEE ALSO MEDWATCH #221098-2008-00768. THE SAME PT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT AN ENDOMETRIAL THERMAL ABLATION PROCEDURE IN 2008. DURING THE THIRD ATTEMPT TO ACHIEVE THERAPY TEMPERATURE, THE PRESSURE QUICKLY DROPPED. ABOUT 45CC OF D5W WAS BEING USED AT THE TIME. THE PROCEDURE NEVER GOT TO THE THERAPY CYCLE. THERE WERE TWO TO THREE PREHEAT CYCLES WHICH DID NOT REACH THE EIGHTY SEVEN DEGREES TO ENTER THE THERAPY CYCLE. THE PT WAS MOVING AND THE PRESSURE DROPPED. THE PROCEDURE WAS ABORTED AND THE SURGEON PLACED A COLD WATER SPONGE IMMEDIATELY INTO THE VAGINA. WHEN THE BALLOON WAS REMOVED FROM THE PT, IT WAS NOTICED THAT THE BALLOON HAD RUPTURED. THE PT REMAINED OVERNIGHT IN THE HOSPITAL FOR OBSERVATION AND WAS FOUND TO HAVE CERVICAL AND VAGINAL BURNS. THE PT WAS TREATED WITH SILVADENE INTRAVAGINAL APPLICATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACHOICE CATHETER, BALLOON, TRANSCERVICAL MKN ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R