MAUDE Adverse Event Report: ANGIODYNAMICS, INC. SOLERO; MICROWAVE TISSUE ABLATION APPLICATOR

Model Number	700106001-US
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	03/24/2026
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 distributor reported an end user experienced an issue when using a 14cm solero applicator.The treating physician planned to percutaneously treat four liver lesions during the ablation procedure.The applicator was successfully tested for 10 seconds at 100 watts.The unit was set for 140 watts for 4 minutes to treat the first lesion, the second lesion ablation was set for 140 watts for 2 minutes, and the third lesion ablation was set for 100 watts for 2 minutes.One minute into the ablation for the third lesion, the unit displayed an error 209 "coolant temperature >52".The unit was turned off and restarted after 2 minutes and the procedure was proceeded to treat the fourth lesion.The applicator had been removed and inspected between each ablation cycle.The fourth lesion treatment was performed at 140 watts for 1 minute.When the radiologist removed the applicator, it was noted the ceramic tip of the applicator had broken off inside the patient.The radiologist was confident the tip would not move or migrate, so it was determined to not attempt to remove the tip.The patient did not experience any harm as a result of this incident.

• Brand Name: SOLERO
• Common Device Name: MICROWAVE TISSUE ABLATION APPLICATOR
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 603 queensbury avenue; queensbury, NY 12804
• MDR Report Key: 24909535
• Report Number: 1319211-2026-00132
• Device Sequence Number: 21300898
• Product Code: NEY
• UDI-Device Identifier: H787700106001US0
• UDI-Public: H787700106001US0
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K162449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2026

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 Model Number: 700106001-US
• Device Lot Number: 5857957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/31/2025
• 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 Age: 61 YR
• Patient Sex: Male