BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONATA TRANSCERVICAL FIBROID ABLATION SYSTEM

    MDR report key: 22952723 · Received September 3, 2025

    Report

    Report Number
    3005875675-2025-00032
    Event Type
    Injury
    Date Received
    September 3, 2025
    Date of Event
    August 1, 2021
    Report Date
    September 3, 2025
    Manufacturer
    GYNESONICS
    Product Code
    KNF
    UDI-DI
    10817929020333
    PMA / PMN Number
    K211535
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. GYNESONICS EVALUATION IS THAT THIS EVENT IS MOST LIKELY TRANSIENT BACTEREMIA. BACTEREMIA INFECTION AND CERTAINLY THERE IS NO MERIT TO ANY CONSIDERATION OF "SEPSIS" IN THIS PATIENT; THE TERM IS BEING MISAPPLIED HERE. THERE WAS NO EVIDENCE OF ANY INFECTION, NEITHER ON CULTURE, PHYSICAL EXAM NOR BLOOD TESTING, VITAL SIGNS AND IMAGING. THE PATIENT EXPERIENCED SYMPTOMS CONSISTENT WITH A POSTABLATION INFLAMMATION SYNDROME, AND IN GENERAL, INTRAUTERINE INFECTION WOULD MORE LIKELY HAVE MANIFESTED ITSELF VERY CLEARLY. 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

    ON (B)(6) 2021, IT WAS INITIALLY REPORTED TO GYNESONICS THAT A PATIENT TREATED WITH THE SONATA SYSTEM EXPERIENCED COMPLICATIONS. PATIENT PRESENTED 1-DAY POST-TFA W/CENTRAL NEUROLOGICAL SYMPTOMS (PHOTOPHOBIA, HEADACHE, ETC.), HAD A POSITIVE BLOOD CULTURE FOR GRAM-NEGATIVE BACILLI. PATIENT AFEBRILE, HER LAB VALUES W/NO ABNORMALITIES SUGGESTIVE OF INFECTION; PELVIC IMAGING NEGATIVE FOR A FLUID COLLECTION. NO COMPLAINTS OR EXAM FINDINGS CONSISTENT WITH ANY GYNECOLOGIC INFECTION OR ACUTE ABNORMALITY. IN THE ABSENCE OF ANY LABORATORY AND EXAM FINDINGS CONSISTENT WITH INFECTION, THE ABSENCE OF MULTIORGAN DYSFUNCTION SUGGESTIVE OF SEPSIS, AND WITH THE UNEXPLAINED, NONINFECTIOUS NEUROLOGIC SYMPTOMATOLOGY THAT REPRESENTED THE PATIENT'S CHIEF COMPLAINT, THE MOST TENABLE DIAGNOSIS IS "TRANSIENT BACTEREMIA WITH CENTRAL NEUROLOGICAL SYMPTOMATOLOGY." BACTEREMIA IS NEITHER SYNONYMOUS WITH INFECTION NOR SEPSIS. RELATIONSHIP TO PROCEDURE COULD NOT BE RULED OUT. MICROBIOLOGIST SUMMARY: REVIEW BOTH THE MICROBIOLOGY AND CLINICAL NOTES: PRESENTED TO (B)(6) HOSPITAL WITH E. COLI SEPSIS 48HR AFTER RADIO ABLATION AT (B)(6). HER SYMPTOMS ON PRESENTATION WERE PRIMARILY CNS RELATED (HEADACHE, PHOTOPHOBIA, NECK STIFFNESS, NAUSEA) THERE WERE NO SYMPTOMS RELATING TO THE GENITOURINARY TRACT. MENINGITIS AS A CAUSE OF SEPSIS WAS EXCLUDED. ALTHOUGH THE SEPSIS WAS TEMPORALLY RELATED TO THE PROCEDURE AT (B)(6) THERE WERE NO OTHER CLINICAL FEATURES OR INVESTIGATIONS WHICH LINKED THE SEPSIS TO THE PROCEDURE SPECIFICALLY CT IMAGING OF THE PELVIS DID NOT IDENTIFY ANY UTERINE SOURCE OF THE INFECTION NOR ANY PELVIC COLLECTION. UNFORTUNATELY, NO URINE SAMPLE WAS SUBMITTED ON ADMISSION, A SAMPLE WAS SUBMITTED THE FOLLOWING DAY WHICH DEMONSTRATED SOME PYURIA BUT NO GROWTH ON CULTURE, THIS RESULT IS MOST LIKELY A CONSEQUENCE OF THE EMPIRICAL ANTIBIOTIC THERAPY RECEIVED. IN SUMMARY NO DEFINITIVE SOURCE HAS BEEN IDENTIFIED FOR THIS LADY'S SEPSIS, THE ONLY LINK TO THE PROCEDURE IS THE TIMING OF THE TWO EVENTS BUT A UTI IS, AT LEAST, AN EQUALLY LIKELY SOURCE. AS THE PROCEDURE WAS PART OF A STUDY, I WOULD SUGGEST THIS INCIDENT IS NOTIFIED TO THE TRIAL MONITORING COMMITTEE FOR INFORMATION BUT AS NO DEFINITIVE LINK IS IDENTIFIED I WOULD NOT SUGGEST IT REQUIRES ANY CHANGE IN PROTOCOL AT THIS STAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1335115 SONATA TRANSCERVICAL FIBROID ABLATION SYSTEM ULTRASOUND-GUIDED INTRAUTERINE RADIO-FREQUENCY ABLATION SYSTEM KNF GYNESONICS SONATA2-220 10817929020333

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Hospitalization