BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACHOICE

    MDR report key: 1335055 · Received March 4, 2009

    Report

    Report Number
    2210968-2009-00219
    Event Type
    Injury
    Date Received
    March 4, 2009
    Date of Event
    September 15, 2008
    Report Date
    February 4, 2009
    Manufacturer
    ETHICON, INC.
    Product Code
    MKN
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2009-00220. THE SAME PT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT AN ENDOMETRIAL THERMAL ABLATION PROCEDURE IN 2008. AFTER COMPLETING THE PROCEDURE, THE SURGEON NOTED THAT HE HAD INADVERTENTLY FORGOTTEN TO REMOVE A MIRENA INTRAUTERINE SYSTEM. THE SURGEON THEN REMOVED THE DEVICE. THE PT EXPERIENCED UTERINE BLEEDING. THE SURGEON STATED THAT HE FELT THAT THE PRESENCE OF THE MIRENA MIGHT INTERFERE WITH THE EFFECTIVENESS OF THE THERMAL ABLATION TREATMENT, SO HE REPEATED ANOTHER EIGHT MINUTE THERMAL ABLATION TREATMENT CYCLE. THE PT DID WELL EXCEPT FOR POST-OPERATIVE PAIN, WHICH WAS MANAGED WITH ORAL ANALGESICS. AN ULTRASOUND OF THE UTERUS PERFORMED ON AN UNK DATE, FOUND A THICKENED ENDOMETRIUM OF 15MM AND A VASCULAR NODULE IN THE FUNDUS OF 1.5 CM. CURRENTLY, THE PT IS IN GOOD CONDITION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MIRENA INTRAUTERINE SYSTEM