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	04/13/2026
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 19cm solero applicator.The applicator was tested for 10 seconds at 120 watts per protocol with no issues.The applicator was placed for the percutaneous microwave procedure of the liver, with the unit set for 5 minutes, 120watts.A "high reflected power, reposition probe and try again" was received approximately 15 seconds after the ablation started.The applicator was withdrawn to reposition it at which time it was noted the tip had detached inside of the patient's liver.Another applicator was used to complete the procedure.The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: 24904983
• Report Number: 1319211-2026-00134
• Device Sequence Number: 21107881
• Product Code: NEY
• UDI-Device Identifier: H787700106002US0
• UDI-Public: H787700106002US0
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

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: 5812708
• 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: 04/13/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2024
• 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: 54 YR
• Patient Sex: Male
• Patient Weight: 84 KG