BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACHOICE CATHETER UNKNOWN PRODUCT

    MDR report key: 8143570 · Received December 7, 2018

    Report

    Report Number
    2210968-2018-77590
    Event Type
    Injury
    Date Received
    December 7, 2018
    Report Date
    December 12, 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). IT WAS REPORTED THAT THIS DEVICE IS NOT MALFUNCTION REPORTABLE. THEREFORE, THIS MEDWATCH REPORT IS NOT REPORTABLE. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? -NO. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? -NO, THESE ARE ALL KNOW AND EXPECTED RISKS OF ABLATION IN GENERAL AND NOT SPECIFIC TO THERMACHOICE. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT INVOLVED? - NO.

    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. CITATION: BJOG 2014; 121: 748¿754. DOI: 10.1111/1471-0528.12585 - (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: MICROWAVE ENDOMETRIAL ABLATION VERSUS THERMAL BALLOON ENDOMETRIAL ABLATION (MEATBALL): 5-YEAR FOLLOW UP OF A RANDOMISED CONTROLLED TRIAL". AUTHORS: AM SAMBROOK, A. ELDERS, KG COOPER. CITATION: BJOG 2014; 121: 748¿754. DOI: 10.1111/1471-0528.12585. THE OBJECTIVES OF THE STUDY WAS TO COMPARE LONG-TERM OUTCOMES FOLLOWING MICROWAVE ENDOMETRIAL ABLATION (MEA) AND THERMAL BALLOON ABLATION (TBALL). THIS IS A FOLLOW-UP OF A PROSPECTIVE, DOUBLE-BLIND RANDOMIZED CONTROLLED TRIAL AT 5 YEARS AT A TEACHING HOSPITAL IN THE UK WITH 320 WOMEN REQUESTING FOR AN ENDOMETRIAL ABLATION. OF WHICH, 157 PATIENTS WERE RANDOMIZED UNDER MEA AND 157 PATIENTS (AGE: 43.2 YEARS; BMI: 27.8) WERE RANDOMIZED UNDER TBALL. IN THE TBALL GROUP, THERMACHOICE 3 (ETHICON) WAS USED DURING THE PROCEDURE. IN THE TBALL GROUP, REPORTED COMPLICATIONS INCLUDED PAIN (N-1) WHICH REQUIRED HYSTERECTOMY, LIGHT BLEEDING (N-34), HEAVY BLEEDING (N-6) WHICH REQUIRED HYSTERECTOMY IN 1 PATIENT, COMBINED PAIN AND BLEEDING (N-4) WHICH REQUIRED HYSTERECTOMY, AND FIBROID PRESSURE SYMPTOMS (N-1) WHICH REQUIRED HYSTERECTOMY. THIS TRIAL CONFIRMS THAT THERMACHOICE 3 ENDOMETRIAL ABLATION (ETHICON) ACHIEVED COMPARABLE LONG-TERM RESULTS TO MICROWAVE ENDOMETRIAL ABLATION, WHICH IS ONE OF THE MOST ROBUSTLY EVALUATED SECOND-GENERATION DEVICES. THESE RESULTS ENHANCE CHOICE FOR THE GYNECOLOGIST AND REDUCE THE LIKELIHOOD OF A MONOPOLY SITUATION ARISING FOR THE SUPPLY OF ENDOMETRIAL ABLATION TECHNOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982578 THERMACHOICE CATHETER UNKNOWN PRODUCT DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention