BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY

    MDR report key: 3843139 · Received June 2, 2014

    Report

    Report Number
    2210968-2014-06921
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 16, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    MNB
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PREOPERATIVE DIAGNOSIS WAS MENORRHAGIA. THE BALLOON BURST AFTER THE START BUTTON WAS HIT. THE CATHETER PARTLY TORE OFF FROM THE SHAFT. CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY AND FUNCTIONALLY EVALUATED. UPON EVALUATION, THE CATHETER FAILED THE LEAK TEST BECAUSE THE BALLOON WAS BROKEN IN ZONE A. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFO 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 ON (B)(6) 2014. DURING THE PROCEDURE, THE PRESSURE AND TEMPERATURE KEPT FLUCTUATING AND ALL OF A SUDDEN THE GENERATOR SHOWED THAT IT HAD OVERHEATED, EVEN THOUGH THE TEMPERATURE WAS ONLY 78 DEGREES CELSIUS ON THE MONITOR. THE GENERATOR CUT OUT AND CATHETER WAS REMOVED, MACHINE SWITCHED OFF AND WHOLE PRIMING PROCEDURE WAS DONE AGAIN. AT THIS STAGE THE PRESSURE DID NOT WANT TO RISE, EVEN THOUGH THE SURGEON HAD INSERTED ABOUT 25ML OF FLUID INTO THE CATHETER. THE CATHETER WAS AGAIN REMOVED TO CHECK FOR LEAKAGES AND INSERTED INTO PATIENT. THE PHYSICIAN TRIED TO FILL CATHETER, WHICH DID NOT WANT TO INFLATE, AND THEN SUDDENLY THE CATHETER BURST WHILE INSIDE THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322330 GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB ETHICON INC. UNK GLMH03

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR