BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACHOICE

    MDR report key: 1623245 · Received February 24, 2010

    Report

    Report Number
    2210968-2010-00149
    Event Type
    Malfunction
    Date Received
    February 24, 2010
    Date of Event
    January 26, 2010
    Report Date
    January 26, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    MKN
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4). CONCLUSION: 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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENDOMETRIAL THERMAL ABLATION PROCEDURE ON (B)(6) 2010. DURING THE PROCEDURE, THERE WERE PRESSURE FLUCTUATIONS ONE MINUTE AND FOURTEEN SECONDS INTO THE THERAPY CYCLE. THE PATIENT HAD BEEN SOUNDED TO APPROXIMATELY 9.5 CM. TWENTY CUBIC CENTIMETERS OF FLUID WAS INSERTED INTO THE CAVITY. IT IS UNKNOWN HOW MUCH WAS EXTRACTED. A HYSTEROSCOPY WAS PERFORMED. WHEN THE BALLOON WAS REMOVED, A HOLE WAS NOTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SECOND LIKE DEVICE 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 BKMG09

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK