BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACHOICE

    MDR report key: 1193500 · Received October 8, 2008

    Report

    Report Number
    2210968-2008-00955
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    July 29, 2008
    Report Date
    September 12, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    MKN
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Product Problem
    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 INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENDOMETRIAL THERMAL ABLATION PROCEDURE IN 2008. DURING THE PROCEDURE, THE PATIENT BEGAN MOVING, CAUSING THE PHYSICIAN TO WITHDRAW THE CATHETER. UPON EXAMINATION OF THE CATHETER, IT WAS FOUND TO HAVE "BROKEN CLEAR PLASTIC ON THE FAR END." ALL OTHER PARTS WERE INTACT. THE TIP OF CATHETER EXCEPT THE CLEAR PLASTIC WAS ATTACHED ON THE PROXIMAL END. THE PATIENT WAS ADMITTED TO THE HOSPITAL OVERNIGHT FOR OBSERVATION. THERE WERE 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 29 YR