BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACHOICE

    MDR report key: 949637 · Received November 19, 2007

    Report

    Report Number
    2210968-2007-01071
    Event Type
    Malfunction
    Date Received
    November 19, 2007
    Date of Event
    October 11, 2007
    Report Date
    October 26, 2007
    Manufacturer
    ETHICON, INC.
    Product Code
    MKN
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 11/19/2007. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210938-2007-01070. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENDOMETRIAL THERMAL ABLATION PROCEDURE IN 2007. DURING THE PROCEDURE, THE CATHETER FILLED WITH NO APPARENT LEAKS BUT, WHEN THE SURGEON "PRIMED" THE CATHETER, IT WOULD NOT HOLD POSITIVE PRESSURE. THE CATHETER WAS REMOVED AND A HOLE WAS NOTICED IN THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER CATHETER WITH NO ADVERSE PATIENT CONSEQUENCES.

    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 YR