BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACHOICE CATHETER UNKNOWN PRODUCT

    MDR report key: 8133856 · Received December 5, 2018

    Report

    Report Number
    2210968-2018-77527
    Event Type
    Injury
    Date Received
    December 5, 2018
    Report Date
    November 19, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    MNB
    PMA / PMN Number
    P970021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? WEB ADDRESS: CITATION: BJOG. 2013; 120: 966¿970. DOI: 10.1111/1471-0528.12213. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: "TEN-YEAR FOLLOW-UP OF A RANDOMISED CONTROLLED TRIAL COMPARING BIPOLAR ENDOMETRIAL ABLATION WITH BALLOON ABLATION FOR HEAVY MENSTRUAL BLEEDING." AUTHORS: MC HERMAN, JPM PENNINX, BW MOL, MY BONGERS. WEB ADDRESS: CITATION: BJOG. 2013; 120: 966¿970. DOI: 10.1111/1471-0528.12213. THE OBJECTIVE OF THE STUDY WAS TO EVALUATE THE RESULTS AT 10 YEARS AFTER TREATMENT, BIPOLAR ENDOMETRIAL ABLATION IN THE TREATMENT OF HEAVY MENSTRUAL BLEEDING. THE STUDY INCLUDED 126 PRE-MENOPAUSAL WOMEN SUFFERING FROM HEAVY MENSTRUAL BLEEDING. THIS REPORT WAS BASED ON A RANDOMISED CONTROLLED TRIAL COMPARING THE BIPOLAR RADIOFREQUENCY IMPEDANCE-CONTROLLED ENDOMETRIAL ABLATION DEVICE AND THE THERMACHOICE THERMAL BALLOON ABLATION DEVICE (ETHICON), WHICH WAS PERFORMED IN THE MAXIMA MEDICAL CENTRE IN THE NETHERLANDS BETWEEN NOVEMBER 1999 AND JULY 2001. IN THE THERMAL BALLOON ABLATION DEVICE GROUP, REPORTED COMPLICATIONS INCLUDED DYSMENORRHEA (N-16), PRESENCE OF CLOTS (N-22), HEAVY MENSTRUAL BLEEDING (N-3) WHICH REQUIRED HYSTERECTOMY, ABDOMINAL PAIN OF UNKNOWN CAUSE (N-1) WHICH REQUIRED HYSTERECTOMY, AND PELVIC ORGAN PROLAPSE (N-1) WHICH REQUIRED HYSTERECTOMY. THE SUPERIORITY OF BIPOLAR ABLATION OVER BALLOON ABLATION IN THE TREATMENT OF HMB, WHICH WAS OBSERVED AT 1 AND 5 YEARS AFTER INITIAL TREATMENT, WAS NO LONGER EVIDENT AFTER 10 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975523 THERMACHOICE CATHETER UNKNOWN PRODUCT DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention