BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONATA TRANSCERVICAL FIBROID ABLATION SYSTEM

    MDR report key: 22909883 · Received August 27, 2025

    Report

    Report Number
    3005875675-2025-00012
    Event Type
    Injury
    Date Received
    August 27, 2025
    Date of Event
    March 21, 2022
    Report Date
    August 27, 2025
    Manufacturer
    GYNESONICS
    Product Code
    KNF
    UDI-DI
    10817929020326
    PMA / PMN Number
    K211535
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO REPORT OF DEVICE MALFUNCTION DURING THE PROCEDURE AND THE SYSTEM FUNCTIONED AS EXPECTED. SUBMISSION OF THIS REPORT IS ASSOCIATED WITH THE RECENT ACQUISITION OF GYNESONICS BY HOLOGIC, INC. DURING THE INTEGRATION INTO HOLOGIC'S ADVERSE EVENT REPORTING SYSTEM AND PROCEDURES, A REVIEW OF HISTORICAL ADVERSE EVENTS WAS PERFORMED. AS A RESULT, THIS EVENT WAS IDENTIFIED AS BEING REPORTABLE ON (B)(6) 2025 AND IS BEING REPORTED RETROACTIVELY OUT OF AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 0

    THIS PATIENT WAS TREATED ON (B)(6) 2021 AND RECEIVED THREE ABLATIONS IN A 7-CM TRANSMURAL ANTERIOR FIBROID (ALONG WITH A SMALLER TYPE 4 MYOMA THAT WAS ABLATED FIRST, ALSO ANTERIOR). SHE NOTED POSTOP LEUKORRHEA THAT HAS PERSISTED. ON MR, IT APPEARS THAT THERE IS A TRACT FROM THE CENTER OF THE FIBROID TO THE ENDOMETRIAL CAVITY THAT MIGHT BE INVOLVED IN THE PERSISTENT DISCHARGE. THE FIBROID, WHICH WAS 6.8 CM ON BASELINE U/S IS NOW AROUND 5.8 CM ON MR (I CALCULATED AN APPROXIMATE 38% REDUCTION IN VOLUME OVER THE PAST FIVE MONTHS). THE PATIENT MAY BE OFFERED A HYSTEROSCOPIC PARTIAL MYOMECTOMY TO CLEAR THE FIBROID TISSUE ABUTTING THE CAVITY (THERE DOES NOT APPEAR TO BE ANY EXTRUSION OF THE FIBROID INTO THE CAVITY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1419251 SONATA TRANSCERVICAL FIBROID ABLATION SYSTEM ULTRASOUND-GUIDED INTRAUTERINE RADIO-FREQUENCY ABLATION SYSTEM KNF GYNESONICS SONATA2-110 10817929020326

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention