MAUDE Adverse Event Report: GYNESONICS SONATA RADIOFREQUENCY ABLATION HANDPIECE; SONOGRAPHY-GUIDED TRANSCERVICAL FIBROID ABLATION SYSTEM

Model Number RFA-002

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2021

Event Type  malfunction  

Event Description

Event: it was originally reported on (b)(6) 2021 by gynesonics representative attending the case, the physician made a total of 4 ablations in a large transmural fibroid without incident.After this he attempted to target and ablate a smaller type 5 myoma.The introducer was inserted uneventfully.However, the needle electrodes were not able to deploy fully.Despite multiple attempts they did not fully deploy to the fiducials and this generated a system error informing the user that the rfa handpiece failed and the handpiece should be replaced.Outside the patient, the physician tried to push the electrodes forward, but it was not possible.This complaint was triaged based on this information as not reportable on (b)(6) 2021.Investigation findings: during investigation of the rfa handpiece on jan 20, 2022, it was discovered that a portion of the center electrode approximately 0.3" by.016" or 8.5mm by 0.4mm had broken off and was missing.Additional information: on jan 26, 2022, gynesonics medical director contacted initial reporter who was present during the procedure to ask for more information regarding the event.The gynesonics representative agreed that there was no evidence on the ultrasound image of any microcalcification but the physician had remarked that he encountered some resistance when trying to deploy the needle electrodes.On jan 31, 2022, gynesonics medical director spoke with the gynecologist, who had not heard of any complications or complaints from the patient.He understood the situation and indicated he will bring his patient in for further evaluation.

Manufacturer Narrative

The rfa handpiece was dismantled to determine the cause of failure.Nothing within the handle mechanism was out of place or broken.All solder joints on the pcb board were intact and did not show a broken temperature controller.There was no obstruction within the handle that can explain the inability to fully deploy electrodes was observed.The introducer and electrode subassemblies were carefully pulled out of the shaft.The introducer hypotube was carefully grounded to reveal the electrodes within.It was found that the center electrode buckled inside the introducer tube preventing the electrode subassembly from further deployment.This suggests excessive force was used to penetrate a very hard fibroid causing the needle electrodes to bend, disform and break.Probable cause of the failure was excessive force used to penetrate a very hard fibroid causing the needle electrodes to bend, disform and break.There is no indication of device malfunction as the physician had successfully performed 4 ablations prior to this failure.

• Brand Name: SONATA RADIOFREQUENCY ABLATION HANDPIECE
• Type of Device: SONOGRAPHY-GUIDED TRANSCERVICAL FIBROID ABLATION SYSTEM
• Manufacturer (Section D): GYNESONICS; 600 chesapeake drive; redwood city CA 94063
• Manufacturer (Section G): GYNESONICS; 600 chesapeake drive; redwood city CA 94063
• Manufacturer Contact: diane king ; 600 chesapeake drive; redwood city, CA 94063 ; 6502163883
• MDR Report Key: 13501602
• MDR Text Key: 296304433
• Report Number: 3005875675-2022-00001
• Device Sequence Number: 1
• Product Code: KNF
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K211535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: RFA-002
• Device Catalogue Number: RFA-002
• Device Lot Number: 79893-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SONATA® TRANSCERVICAL FIBROID ABLATION SYSTEM
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Sex: Female