BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONATA TRANSCERVICAL FIBROID ABLATION SYSTEM

    MDR report key: 22964010 · Received September 4, 2025

    Report

    Report Number
    3005875675-2025-00061
    Event Type
    Injury
    Date Received
    September 4, 2025
    Date of Event
    September 23, 2024
    Report Date
    September 4, 2025
    Manufacturer
    GYNESONICS
    Product Code
    KNF
    UDI-DI
    10817929020326
    PMA / PMN Number
    K240503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    40 YO (B)(6) AT THE TIME OF TREATMENT ON (B)(6) 2024, FOR A 4-CM FIBROID. HAD BLEEDING WITH WATERY DISCHARGE ON (B)(6) 2024 TREATING PHYSICIAN AT THAT TIME AND SUGGESTED IT WAS LIKELY DUE TO SLOUGHING. U/S WAS NOT REMARKABLE OTHER THAN FOR SMALL FIBROIDS, CBC WNL. THE PATIENT'S SLOUGHING SX CONTINUED AND WAS PRESCRIBED TXA EARLIER IN (B)(6) 2025. ON (B)(6) 2025, THE PATIENT PRESENTED TO A DIFFERENT HOSPITAL WHERE SHE WAS DIAGNOSED WITH A TIA (RESOLVED ON ANTICOAGULATION) AND WAS ADMITTED FROM (B)(6) THROUGH (B)(6) 2025 DURING WHICH TIME SHE UNDERWENT UAE. REVIEW OF THE PATIENT'S MR TREATING PHYSICIAN NOTED A MOSTLY/ENTIRELY NON-PERFUSED FIBROID ALONG WITH A LARGELY NONPERFUSED FIBROID EXTRUDED INTO THE CAVITY. THERE ARE AT LEAST TWO FIBROIDS NOTED AND IN AGGREGATE ARE AROUND 8 CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017432 SONATA TRANSCERVICAL FIBROID ABLATION SYSTEM ULTRASOUND-GUIDED INTRAUTERINE RADIO-FREQUENCY ABLATION SYSTEM KNF GYNESONICS SONATA2-110 10817929020326

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Hospitalization| R