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	Abnormal Vaginal Discharge (2123); Unspecified Reproductive System or Breast Problem (4513); Bacteremia (4846)
Date of Event	11/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient who experienced a fibroid expulsion after tfa.42 y/o with a 6.7 cm figo type 2-5 underwent d&c (no resection) sonata rfa and placement of mirena iud.7 weeks post op she presented with pain, watery and bloody discharge.She was seen in ed admitted 48 hours and given antibiotic and analgesia passing very small bits of tissue.After discharge she returned to ed presenting with large myoma piece, 4 cm, that aborted.Pathology report: a.The specimen is received fresh with proper patient identification labeled "uterus, possible leiomyoma passed at home" and consists of a 4.7 x 3.8 x 2.8 cm solid mass of pink-tan fibrous tissue a.Final: fragment of leiomyoma with ischemic necrosis.Again, she presented about 4 weeks later and had second piece of myoma removed from the cervical os.The specimen is received fresh with proper patient identification labeled "fibroid".It consists of a single piece of tan-white, firm, fibrous tissue; necrotic tissue, consistent with leiomyoma with ischemic necrosis measuring 1.9 x 1.7 x 0.3 cm." prophylactic abx were not administered to this patient.
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 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: 22929556
• Report Number: 3005875675-2025-00025
• Device Sequence Number: 13031605
• Product Code: KNF
• UDI-Device Identifier: 10817929020326
• UDI-Public: (01)10817929020326(11)190422
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K222304
• 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): 08/29/2025

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: 11/14/2023
• Initial Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PLACEMENT OF MIRENA IUD.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 42 YR
• Patient Sex: Female