BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACHOICE CATHETER UNKNOWN PRODUCT

    MDR report key: 8117971 · Received November 29, 2018

    Report

    Report Number
    2210968-2018-77414
    Event Type
    Injury
    Date Received
    November 29, 2018
    Report Date
    November 15, 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. CITATION: BJOG: AN INTERNATIONAL JOURNAL OF OBSTETRICS AND GYNAECOLOGY. 2013; 120(1): 24. DOI: HTTP://DX.DOI.ORG/10.1111/1471-0 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE : A CASE REPORT OF PLACENTA PERCRETA AFTER THERMACHOICE BALLOON ENDOMETRIAL ABLATION." AUTHOR : AL-SAYEGH H.; KUNTAL S.; EL-GARIB A.; PARVEEN S.; LEWIS S CITATION: BJOG: AN INTERNATIONAL JOURNAL OF OBSTETRICS AND GYNAECOLOGY. 2013; 120(1): 24. DOI: HTTP://DX.DOI.ORG/10.1111/1471-0... THE OBJECTIVES OF THE STUDY WAS TO HIGHLIGHT THE IMPORTANCE OF ADVISING ABOUT RELIABLE CONTRACEPTION POST ENDOMETRIAL ABLATION. A (B)(6) WOMAN WHO HAD PREVIOUS EMERGENCY CAESAREAN SECTION 3 YEARS AGO FOR FAILURE TO PROGRESS COMPLICATED WITH SEVERE POSTPARTUM HAEMORRHAGE AND ADMISSION TO ITU. SHE IS KNOWN TO HAVE FACTOR V LEIDEN DEFICIENCY AND HISTORY OF PULMONARY EMBOLISM SUFFERED FROM MENORRHAGIA. THE MEDICAL MANAGEMENT HAD FAILED AND THE PATIENT UNDERWENT THERMACHOICE (ETHICON) ENDOMETRIAL ABLATION. REPORTED COMPLICATIONS INCLUDED SEPSIS, FUNDAL PLACENTA PERCRETA, AND MASSIVE HEMORRHAGE WHICH REQUIRED EMERGENCY CESAREAN SECTION AND CESARIAN HYSTERECTOMY TO CONTROL BLEEDING. PREGNANCY AFTER ALL FORMS OF ENDOMETRIAL ABLATION IS ASSOCIATED WITH RISKS OF MORBID ADHESION OF THE PLACENTA, UTERINE RUPTURE, INTRAUTERINE GROWTH RESTRICTION AND PREMATURE RUPTURE OF MEMBRANES RELIABLE METHODS OF CONTRACEPTION SHOULD BE ADVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955512 THERMACHOICE CATHETER UNKNOWN PRODUCT DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention