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

Model Number	700106001-US
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	01/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A pmcf survey reported that a patient diagnosed with hepatocellular carcinoma (hcc) experienced hypotension during a solero microwave thermal ablation procedure using a 14cm solero probe.The 14cm solero probe was placed percutaneously in the patient's liver under ct and fluoroscopy imaging.The size of the target area was 3cm x 2.5cm x 2.5cm.The probe was placed successfully with the distal tip visualized via imaging.The surgical technique of hydrodissection was used.One ablation was performed and completed at 100 watts for 4 minutes.During that time, the patient experienced hypotension which was able to be resolved after pausing the ablation and giving the patient medication.The patient had not been previously treated with any other devices or medication prior to this solero procedure.
Additional Manufacturer Narrative
The device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference: (b)(4).
Additional Manufacturer Narrative
The reported feedback from the pmcf survey that the patient exhibited hypotension during a microwave ablation session cannot be confirmed due to the patient centric nature of this patient adverse event.There was no reported malfunction or performance issue with the solero microwave ablation system.Cardiac issues are an anticipated procedural complication of the solero microwave system use per the device risk management documentation.A dhr review was not conducted since there was no reported lot number.A dhr review of the ship history report (shr) lots could also not be conducted since the probe size (14cm) is known but the specific upn is unknown.In addition, there was no report of solero microwave system malfunction during the procedure, just patient adverse event of hypotension.Labeling review: the directions for use (dfu) which is supplied with this device contains the following statements: intended use/indications for use the solero microwave tissue ablation (mta) system and accessories are indicated for the ablation of soft tissue* during open, laparoscopic, or percutaneous procedures.Testing the device prior to placing the device in the target tissue for ablation, place the tip of the device (including the black shaded zone of the shaft) in a container of sterile water or saline and activate the device at 100 watts for 10 seconds to ensure that the system is functional.Warning: do not initiate the procedure/anesthesia until the applicator has been connected, primed, and the generator status bar indicates "ready".Precautions 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.Each applicator may be used to ablate up to three separate areas of target tissue for each patient at the maximum power and time setting.Inspect the applicator after each ablation.If the applicator appears damaged, utilize another applicator for subsequent ablations.Warning: do not bend the applicator as this may impair the function of the cooling system and may damage the microwave feed line inside the applicator.Warning: when using percutaneously the tip of the antenna may be used to puncture the skin at the point of insertion.Use the minimum force necessary to achieve this 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.Operational instructions 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.Do not use the solero generator if it has been dropped or damaged.Warning: 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
• 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 ; 26 forest street; marlborough, MA 01752
• MDR Report Key: 24321991
• Report Number: 1319211-2026-00027
• Device Sequence Number: 18560549
• Product Code: NEY
• UDI-Device Identifier: H787700106001US0
• UDI-Public: H787700106001US0
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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: 700106001-US
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown