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

Model Number 12740000

Device Problem Energy Output Problem (1431)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2022

Event Type  malfunction  

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).Report references: device 1: (b)(4) ,1317056-2022-00044; device 2: (b)(4) ,1317056-2022-00050; device 3: (b)(4) ,1317056-2022-00051; device/generator 1: (b)(4) , 1317056-2022-00053; device/generator 2: (b)(4).

Event Description

Device 5 of 5: a distributor reported an issue with several different solero devices; one 14cm applicator, two 19cm applicators, and 2 solero units.During pre-procedure testing, with the patient sedated, repeated "high reflected power" error messages occurred with the devices.It was determined the procedure could not be performed due to this event, and the patient was woken up from anesthesia.The patient did not experience any adverse effects, harm, or require medical intervention because of this incident.This event meets the criteria a reportable adverse event; patient safety risk as treatment was not provided, but patient had been sedated.

Manufacturer Narrative

Returned for evaluation was a solero unit, serial number (b)(6).Functional check: unit is in good physical condition.Unit will have microwave generator solid state replaced and calibrated and electrical safety tested.The fault is confirmed as reported.Unit requires the microwave generator solid state to be replaced.Unit passed calibration procedure and then functional test procedure and electrical safety test.Unit passed all acceptance criteria.The reported complaint description is confirmed.High reflected power was able to be replicated during the functional test.The root cause for the high reflective power was determined to be caused by a fault with the solid state generator, which was replaced.This is the first reported error for this unit for high reflected power.This is the first time the solid state generator has been replaced.The unit was tested with the new solid state generator per svc-006-s06 functional test and electrical safety per svc-027 and met all acceptance criteria.A review of the device history records (service order history) was performed for the reported serial number (b)(6) for any deviations related to the reported failure mode of the complaint.The review confirmed that the unit met all material, assembly, and performance specification prior to distribution; i.E.No ncr associated with reported failure mode.Labeling review: the user manual, which is supplied to the user with this unit contains the following statements: 6.3 errors.Errors are non-recoverable system failures which require the end user to reboot the system.System errors may be the result of a failure that the end user in general has no ability to correct.System errors will be reported with unique error numbers which must be provided to angiodynamics to facilitate troubleshooting.In the event of a system error please make note of the events leading up to the error, record the error number, and follow the on-screen instructions.If such an error occurs, the solero unit will turn off and disable the microwave source, so there is no risk of immediate harm to the end user or the patient.6.3.2 unrecoverable system errors.Any system error other than the coolant fault will be the result of an underlying problem with the system that the user will be unable to correct.In this case, the system will display an error similar to the one shown (example system error 125).The only differentiation will be the error number reported in the status bar.In this event, the user should note the conditions leading up to the error, record the error number, and report this information to the complaint handling department of angiodynamics.See section 12 for contact information.System errors are unrecoverable and the system should be shut down.It is not recommended that the system be restarted for further procedures until cleared by angiodynamics.6.2.5 high reflected power.The system will display a warning when the reflected power exceeds a preset threshold as shown and abort the ablation.If this occurs, microwave energy is unable to be effectively transferred from the applicator tip into the targeted tissue due to desiccation.Further progress is blocked until the warning is acknowledged.If a "high reflected power" condition is indicated, several sources are possible and warning message will be displayed as shown.The following are several possible sources leading to the "high reflected power" condition: · the applicators active region may not be fully inserted into the tissue or a transient gas pocket may have formed around the applicator tip.Adjust the positioning of the applicator.Adjust time as necessary.Press start/stop button to restart the ablation.· connection to the generator may have been lost.Check the connection to the generator.Adjust time as necessary.Press the start/stop button to restart the ablation.· the applicator may be defective.Replace the applicator with a new one.· if the problem persists, contact angiodynamics inc.For technical support.".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).Report references: device 1: (b)(4) 1317056-2022-00044; device 2: (b)(4) 1317056-2022-00050; device 3: (b)(4) 1317056-2022-00051; device/generator 1: (b)(4) 1317056-2022-00053; device/generator 2: (b)(4) 1317056-2022-00054.

• Brand Name: SOLERO MICROWAVE TISSUE ABLATION SYSTEM
• Type of Device: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES,
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 13654598
• MDR Text Key: 289467689
• Report Number: 1317056-2022-00054
• Device Sequence Number: 1
• Product Code: NEY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K162449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 12740000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male