MAUDE Adverse Event Report: ANGIODYNAMICS SOLERO MICROWAVE TISSUE ABLATION APPLICATOR; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES,

Model Number	700106003-US
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
A physician reported an issue with a 29cm solero applicator.The applicator was placed through the laparoscopic hole, in a bk ultrasound probe,and tested successfully at 100w for 20 seconds.It was noted that use of the bk ultrasound probe, in conjunction with the solero applicator, is a common practice for this physician, who was described as well-experienced with solero devices.After successful testing, the generator was then set to 140w for 3 minutes and the ablation was initiated.After approximately 15 seconds, smoke was noted to be emanating from the tip of the applicator and the generator displayed a "high reflected power" error message.At this time, it was noted that the tip had detached cleanly, in 2 pieces, from the applicator and remained inside of the patient's liver.The condition of the liver was reported to have appeared "normal," with no evidence of cirrhosis.The tip fragments were removed through the existing laparoscopic incision, with minimal difficulty.The procedure was completed with another same device and the patient did not experience any adverse effects or harm as a result of this issue.The physician does not believe that this event was the result of an applicator failure but from having placed the tip of the applicator too close to the ultrasound probe.
Additional Manufacturer Narrative
Returned for evaluation was one 29cm solero applicator.As received, the ceramic tip was detached and the probe shaft was bent.The ceramic tip of the device was broken off approx.3mm from the end of the steel shaft.This coincides with the end of the semi-rigid outer jacket and is the location where there is a thermal concentration during ablation.From the dark charring and melted silicone coating this device appears to have had an excessive thermal event occur at the point of failure.The copper center conductor has been melted and the ceramic tip fractured.After that occurs there is nothing left to retain the tip.The applicator handle was disassembled and the mcx cap was removed.There were no signs of fluid ingress into the mcx indicating a good shrink boot seal.The root cause of the tip detachment was determined to be a result of a thermal event that fractured the ceramic tip, however, a definitive root cause could not be determined.The customer's reported complaint description of tip fractured/detached is confirmed.The root cause of the high reflected power error message could not be confirmed but is potentially a result of the tip detachment.A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.The review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.Labeling review: the instructions for use, item number which is supplied to the user with the solero applicators contains the following statements; "inspect all devices and packaging for damage prior to use.Do not use any devices that are damaged or if the sterile barrier is breached."the solero microwave tissue ablation (mta) system and accessories are indicated for the ablation of soft tissue during open procedures.Avoid placing lateral forces on the applicator tip during placement or removal.Always use the lowest power and shortest time necessary to achieve the targeted ablation.Inspect the applicator after each ablation.If the applicator appears damaged, utilize another applicator for subsequent ablations.Warning: when placing the device, use the minimum force necessary and take care not to over advance the applicator.Refer to the shaft depth markings to monitor placement depth.Take care to not bend the tip as it may cause damage to the device.Do not energize the applicator unless the active region of the applicator is fully inserted into target tissue.If the applicator is not properly located into the selected tissue, an unintended thermal injury may occur.After each ablation inspect the applicator for any damage.If any damage is observed the applicator should be discarded and replaced with a new applicator." a review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).

• Brand Name: SOLERO MICROWAVE TISSUE ABLATION APPLICATOR
• Common Device Name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES,
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 13840062
• Report Number: 1317056-2022-00058
• Device Sequence Number: 20016537
• Product Code: NEY
• UDI-Device Identifier: H787700106003US0
• UDI-Public: H787700106003US0
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: 700106003-US
• Device Catalogue Number: 700106003
• Device Lot Number: 5684628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2022
• Supplement Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 03/21/2022
• Supplement Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female