MAUDE Adverse Event Report: GYNESONICS SONATA TRANSCERVICAL FIBROID ABLATION SYSTEM; ULTRASOUND-GUIDED INTRAUTERINE RADIO-FREQUENCY ABLATION SYSTEM

Model Number	SONATA2-110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Sepsis (2067); Bacteremia (4846)
Date of Event	09/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was treated on (b)(6) 2024 for four symptomatic intramural, transmural and submucous fibroids ranging in size from 2-5 cm.Of note, the patient received prophylactic metronidazole.The case was uncomplicated.(b)(6) 2024: the patient developed f&c but then defervesced.(b)(6) 2024: recurrent fevers at home.(b)(6) 2024: patient called to report temp of 104º f and had obvious rigors, and was sent to the ew for evaluation.Upon arrival, was noted to be obtunded, as well as agitated and required restraints.Tox screen negative, acetaminophen levels not at toxic levels.Pancultured.Started on broad spectrum parenteral abx and admitted.Developed hypotension requiring pressors and was admitted to the icu.Imaging, including abdominopelvic ct and an hct, all negative.Some lfts slightly elevated.By the late afternoon, the patient was markedly better, no longer agitated or obtunded, and conversing freely.Very importantly, there was no signs/symptoms of endometritis or other pelvic infection.(-) cv19; (-) influenza bc + for staphylococcus lugdunensis and coagulase (-) streptococcus pseudoporcinus, both of which are skin flora.9/11: patient is doing much better and remains in the icu only because of a lack of floor beds.C+s are still pending for the two pathogens.The patient by definition had bacteremia from two unusual skin pathogens, and a diagnosis of sepsis is suggested by the need for pressor support due to hypotension, a clouded sensorium and some slightly elevated lfts, all consistent with multiorgan dysfunction as required for the diagnosis.However, this is not related to tfa as there was no evidence of a pelvic source of infection, the patient received prophylaxis for pelvic coverage (in this case, flagyl®) and the two pathogens are unusual and could be skin flora that could have been introduced during venipuncture.Staphylococcus lugdunensis is usually found among the skin flora.Streptococcus pseudoporcinus is found in the female genital tract but infection is exceedingly rare (only four cases noted in a 2020 paper by khan and colleagues and none of those involved the genital tract but two of the four involved skin cellulitis).
Additional Manufacturer Narrative
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.

• Brand Name: SONATA TRANSCERVICAL FIBROID ABLATION SYSTEM
• Common Device Name: ULTRASOUND-GUIDED INTRAUTERINE RADIO-FREQUENCY ABLATION SYSTEM
• Manufacturer (Section D): GYNESONICS; 200 cardinal way #250; redwood city CA 94063
• Manufacturer (Section G): GYNESONICS; 200 cardinal way; #250; redwood city CA 94063
• Manufacturer Contact: timothy rossi ; 200 cardinal way; #250; redwood, CA 94063 ; 6502416115
• MDR Report Key: 22964004
• Report Number: 3005875675-2025-00055
• Device Sequence Number: 9257707
• Product Code: KNF
• UDI-Device Identifier: 10817929020326
• UDI-Public: (01)10817929020326(11)210809
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K240503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SONATA2-110
• Device Catalogue Number: SONATA2-110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female