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	05/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor reported an end user experienced an issue when using a 19cm solero applicator.During a percutaneous liver tumor ablation procedure, the solero ablation needle experienced a ceramic tip breakage.After unpacking a new applicator, a functional test was performed at 100]w for 30 seconds.The needle functioned normally and was deemed suitable for clinical use.There was no resistance when advancing the applicator and no adjunct tools were used.The first ablation on the target tumor was conducted at a setting of 100 w for 2 minutes and was completed successfully.A second ablation on another tumor was then initiated.To confirm the function of the needle, a second functional test was performed before the official ablation.It functioned normally, and the second ablation was applied at 100 w for 2 minutes.When approximately 1 minute and 26 seconds remained, the displayed output wattage dropped from 82 w to 70 w immediately, and the "high reflected power" warning appeared.The physician was informed of the warning and pulled out the needle to check.Upon removal, only the stainless steel portion of the needle tip was present, the ceramic tip was missing.The broken ceramic tip was confirmed to have remained inside the patient by ultrasound.A new applicator was then used to complete the procedure successfully.Regarding the retained ceramic fragment, the physician stated that follow-up observation and monitoring would be conducted.The physician has used the product for less than 1 year, and the physician has attended ablation training courses.Ablation size was 2cm.
Additional Manufacturer Narrative
The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Additional Manufacturer Narrative
Received one (1) 19cm solero probe.The customer's reported complaint description of ceramic tip was fractured and detached was confirmed.The reported high reflected power warning message could not be confirmed given the condition of the returned probe complaint sample (tip detached).The applicator was received with the ceramic tip partially detached from the distal end of the shaft assembly.The ceramic ferrule and center conductor is completely detached.Approximately 4mm of the tip remained attached there are signs of a thermal event occurring.Center conductor detached internal to semi rigid.There are no known manufacturing defects.The device cartridge was connected to the complaints lab solero generator nest.The pump function was verified and functioned normally.A slow coolant leak was observed from the distal end, unknown if the leak was caused by thermal event.This failure is the result of a thermal event, root cause of which could not be definitively determined.Root cause for the thermal event/tip detachment could not be definitively determined.Capa000112 has been initiated to investigate this failure mode.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 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.Hardware unit review: solero generator s/n (b)(6) was used during this procedure with the probe in question.Unit was manufactured in jun-2017 and the most recent service was: case (b)(4) on 01-feb-2024 for routine service/testing.Unit passed functional testing.Reference (b)(4).

• 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 ; 5086587990
• MDR Report Key: 22166694
• Report Number: 1317056-2025-00145
• Device Sequence Number: 18090074
• Product Code: NEY
• UDI-Device Identifier: H787700106002US0
• UDI-Public: H787700106002US0
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: 5829682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2024
• 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: 75 YR
• Patient Sex: Male