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

Model Number	700106002-US
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/23/2025
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.A patient presented for a percutaneous microwave ablation procedure of the liver.The applicator was successfully tested prior to insertion for 10 seconds at 60 watts.During the microwave procedure, the applicator required multiple positionings.After the second repositioning, it was observed the applicator was slowly leaking saline at the tip.The surgeon continued the procedure as the saline was sterile.During the third cycle, at 2 minutes and 30 seconds of a 6-minute,140 watt cycle, the equipment malfunctioned and stopped working due to a high reflective power message.When mobilizing the antenna, it was observed that the tip wasn't moving.Upon removal of the applicator, it was observed that the tip was broken.No active bleeding was observed in the controls.The procedure was completed with another of the same device.Additional information: device was not removed and examined when repositioned.No adjunct tools were used during the procedure the tip will not be removed.Doctor has been using solero since 2022 total time for the whole procedure was from 2:00 p.M.To 4:06 p.M.Two lesions, one measuring 1.8 cm and the other 2.2 cm.
Additional Manufacturer Narrative
No probe product was returned to angiodynamics for evaluation; however, customer did provide a picture showing the distal portion of the white ceramic tip was fractured and detached.The customer's reported complaint description of probe ceramic tip was fractured and detached was confirmed based on picture provided by the customer, however, no complaint sample was returned.Without receiving product for evaluation a definitive root cause for this event cannot be determined.Capa000112 has been initiated to investigate this failure mode.Device history record review of the packaging/assembly/component lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.Hardware unit review: solero generator s/n (b)(6) was used during this procedure with the probe in question.Unit was manufactured in jul-2024 and there have been no previous service cases/sos for this unit since it was distributed.A complaint search review of the s/n shows no previous repairs, servicing and/or upgrades for this unit associated with probe tip detached failure mode since the unit was distributed.Labeling review: the directions for use (dfu) which is supplied to the user with the solero applicators 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.Reference (b)(4).Correction: d4 lot number.D4 expiration date.

• Brand Name: SOLERO
• Common Device Name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 8007726446
• MDR Report Key: 22461849
• Report Number: 1317056-2025-00170
• Device Sequence Number: 8550947
• Product Code: NEY
• UDI-Device Identifier: H787700106002US0
• UDI-Public: H787700106002US0
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2025

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: 700106002-US
• Device Lot Number: 5832413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2024
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 80 KG