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

Model Number	700106001-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	05/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor reported an issue with a 14cm solero applicator.One minute after starting a liver microwave ablation procedure, a high temperature error occurred.When removing the needle from the patient, the needle was found to be burnt and missing the tip.The tip remains in the patient and the liver tumor ablation procedure could not be completed due to this event.The doctor is waiting for a certain amount of time to proceed with the ablation procedure again and determine how to remove the tip.
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
Updated event description: a distributor reported an issue with a 14cm solero applicator.The applicator was tested for 10 seconds at 100watts in a saline solution.The unit was set for the procedure at 140 watts for 6 minutes.The applicator was percutaneously placed with no noted difficulty.One minute after starting a liver microwave ablation procedure, a high temperature error occurred.When removing the needle from the patient, the needle was found to be burnt and missing the tip.The tip remains in the patient and the liver tumor ablation procedure could not be completed due to this event.The doctor is waiting for a certain amount of time to proceed with the ablation procedure again and determine how to remove the tip.Additional information: this was the second procedure performed by the doctor, who was accompanied by a support representative from rp médicas, experienced in several previous procedures.She reports that this is the first time a situation like this has occurred.Ablation size: approximately 4.1 a 4.9.
Additional Manufacturer Narrative
New information: patient information: a1, a2, a3, a4, b5 event description.Reference (b)(4).
Additional Manufacturer Narrative
The customer's reported complaint description of the ceramic tip was fractured/detached is confirmed.The reported of high temperature 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 3mm 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 complaint's lab solero generator nest.The pump function was verified and functioned normally.This failure is the result of a thermal event, root cause of which could not be definitively determined.Hardware unit review: solero generator s/n (b)(6) was used during this procedure with the probe in question.Unit was manufactured in feb-2019 and the most recent service was: (b)(4) on 26-nov-2024 for error 209 (b)(4) due to gap in nest.Unit repaired and passed functional testing.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.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.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: 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: 22292536
• Report Number: 1317056-2025-00152
• Device Sequence Number: 15547064
• Product Code: NEY
• UDI-Device Identifier: H787700106001US0
• UDI-Public: H787700106001US0
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2025

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: 700106001-US
• Device Lot Number: 5834177
• 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: 05/27/2025
• Supplement Date Received by Manufacturer: 06/27/2025; 09/12/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 07/01/2025; 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2024
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 60 KG