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	08/28/2024
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A distributor reported an end user experienced an issue when using a 19cm solero applicator.A mwa case was set to be performed percutaneously at100w, 4min burn under us and ct guidance.The lesion had lipiodol stain.The solero applicator was prepared as per the ifu, post first burn, they set up for 140w 2minutes.50 seconds into the burn, a "high reflected power" message displayed.They attempted to do three more ablations with the high reflected power errors.Then the doctor decided to finish and removed probe.It was not immediately noted the tip had detached but was noticed when he cut the probe for disposal.The tip was also noted on the post ablation imaging due to the lipiodol staining (on soft tissue window).He determined that it was not an issue as the tip was ceramic and the removal procedure was too invasive; it was lower risk to leave the tip in-situ.The doctor has been using solero product for 8 years.The ablation size was 3cm.
Additional Manufacturer Narrative
The customer's reported complaint description of "tip detached and remained in the patient" cannot be confirmed.No complaint sample was returned for evaluation.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.Device history record review of the packaging/assembly/component lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.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.Note: the solero microwave tissue ablation (mta) system and accessories are indicated for the ablation of soft tissue, during open, laparoscopic, or percutaneous procedures.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 11-mar-2024 for routine service; passed functional testing.A complaint search review of the s/n shows no previous repairs, servicing and/or upgrades for this unit associated with tip detached failure mode since the unit was distributed.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 ; 5086587990
• MDR Report Key: 21027163
• Report Number: 1317056-2024-00275
• Device Sequence Number: 9045634
• Product Code: NEY
• UDI-Device Identifier: H787700106002US0
• UDI-Public: H787700106002US0
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2025

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 Expiration Date: 07/31/2026
• Device Model Number: 700106002-US
• Device Lot Number: 5797568
• 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: 12/11/2024
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2023
• 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 Sex: Unknown