BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACHOICE

    MDR report key: 1395806 · Received March 31, 2009

    Report

    Report Number
    2210968-2009-00337
    Event Type
    Malfunction
    Date Received
    March 31, 2009
    Date of Event
    February 25, 2009
    Report Date
    March 3, 2009
    Manufacturer
    ETHICON, INC.
    Product Code
    MKN
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 03/30/2009. CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVAL. THE LEAK TEST WAS UNABLE TO BE PERFORMED BECAUSE, THE LUER FITTING WAS DISCONNECTED FROM THE TUBING GOING TO THE TRUMPET VALVE. 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 AN ENDOMETRIAL THERMAL ABLATION PROCEDURE IN 2009. AFTER INSERTING THE DEVICE, IT WAS NOT WORKING IN REGARDS TO PRESSURE. AFTER REMOVING THE DEVICE, THE BALLOON WAS LEAKING. ANOTHER LIKE PRODUCT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE 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 APMG01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK