BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACHOICE

    MDR report key: 1386662 · Received March 19, 2009

    Report

    Report Number
    2210968-2009-00276
    Event Type
    Malfunction
    Date Received
    March 19, 2009
    Date of Event
    February 12, 2009
    Report Date
    February 17, 2009
    Manufacturer
    ETHICON, INC.
    Product Code
    MKN
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 03/19/2009. 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 PT UNDERWENT A THERMAL ENDOMETRIAL ABLATION IN 2009. DURING THE PROCEDURE, THE PRESSURE FELL AT THE BEGINNING OF USE WHEN THE BALLOON WAS INSIDE THE PT. THE CATHETER WAS RETRIEVED BUT NO LEAKAGE WAS DETECTED. THE BALLOON WAS THEN REINTRODUCED AND THE SAME PROBLEM OCCURRED AND LIQUID WAS "GOING OUT OF THE PATIENT". WHEN THE CATHETER WAS REMOVED, THERE WAS LEAKAGE OF THE BALLOON. THERE WAS NO OTHER LIKE DEVICE TO COMPLETE THE PROCEDURE SO THE PROCEDURE WAS STOPPED WITH NO ADVERSE PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACHOICE CATHETER, BALLOON, TRANSCERVICAL MKN ETHICON, INC. NA AGMG09

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK