BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACHOICE

    MDR report key: 1380851 · Received March 20, 2009

    Report

    Report Number
    2210968-2009-00272
    Event Type
    Malfunction
    Date Received
    March 20, 2009
    Date of Event
    February 20, 2009
    Report Date
    February 20, 2009
    Manufacturer
    ETHICON, INC.
    Product Code
    MKN
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 03/20/2009. CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVAL. THE CATHETER FAILED THE LEAK TEST DUE TO A HOLE IN THE BALLOON. IN ADDITION, A REVIEW OF THE BATCH MFG RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOMETRIAL THERMAL ABLATION DEVICE DEMONSTRATION IN 2009, THERE WAS A LOSS OF PRESSURE ONE MINUTE INTO THE THERAPY CYCLE. FLUID WAS NOTED COMING FROM THE PLASTIC UTERINE MODEL AND A HOLE WAS NOTED IN THE BALLOON. THE PROBLEM OCCURRED WHEN THE USER DELIBERATELY JIGGLED THE CATHETER IN AN EFFORT TO CREATE A HEATING ERROR FOR DEMONSTRATION PURPOSES. THERE WAS NO PT INVOLVED IN THE EVENT AND NO ADVERSE PT CONSEQUENCES OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACHOICE CATHETER, BALLOON, TRANSCERVICAL MKN ETHICON, INC. NA APMG08

    Patients

    Seq Age Sex Outcome Treatment
    1 NA