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

Catalog Number 700106003

Device Problems Energy Output Problem (1431); Activation, Positioning or Separation Problem (2906)

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

Event Date 12/29/2020

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 device evaluation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

First probe: a distributor reported an issue with a 29cm solero applicator.During preparation, the applicator passed the test protocol and was used to treat a lesion ablating 60w x 5minutes successfully but on setting a track ablation of 60w x 30 seconds, the system failed to ablate and displayed a "high reflected power" error message.The team rebooted the whole system, disconnected and reconnected the applicator cartridge and re-tried; however, the same error occurred.Another same device was chosen and passed test protocol and successfully completed an ablation 60w x 5mins but failed track ablation of 60w x 30 seconds and displayed a "high reflected power" error message.The team then rebooted the whole system, disconnecting and reconnecting the applicator cartridge and received a yellow" coolant 52-degree temp error" message.The doctor then removed the applicator from the patient and the nursing staff changed the saline bag and rebooted the system and re-tested the applicator.It passed it's test protocol and was placed in another lesion, ablation set at 60w x 5mins; however, 4 minutes into the ablation, an "error: high reflected power" occurred.The track ablation was abandoned and risk of tumor seeding was discussed with the doctor.The patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.It was indicated the reported device is available for return to the manufacturer for a device evaluation.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 probe.During functional testing, no high reflected power (hrp) message was received, as reported.The reported complaint description of hrp could not be confirmed.However, an internal device evaluation of the probe assembly noted a manufacturing related root cause.The complaint technician verified proper device operation at both 60w and 140w settings.The cartridge cover was removed and the n-type was inspected.If fluid gets into the n-type it will trigger an hrp failure.The screw cap was removed and there was no evidence of fluid ingress.The white handle covers were removed to expose the mcx shrink boot.The boot was positioned above the shoulder which can compromise the seal integrity.The fluid appears to have migrated under the heat shrink boot during use.Fluid getting under the boot and into the cable or mcx can trigger an hrp error.The source of the moisture ingress is not certain, but the glue lined heat shrink boot on the mcx is used to seal the mcx to cable connection.A poor seal may allow fluid to get under the boot.The boot on this device was positioned high up on the mcx above the shoulder.This will reduce the contact area on the white cable jacket.The process was revised sept 2020 to better define the boot location on the mcx.The top of the boot is to be set at the shoulder of the mcx.The device in the complaint was produced in march 2020, prior the mcx boot placement change in september 2020.All team members performing this work step are trained to the current document revision.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.Labeling review: the instructions for use, which is supplied to the user with the solero applicators contains the following statements; "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."the solero microwave tissue ablation (mta) system and accessories are indicated for the ablation of soft tissue during open procedures.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.Inspect the applicator after each ablation.If the applicator appears damaged, utilize another applicator for subsequent ablations.Warning: when placing the device, use the minimum force necessary 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.Do not energize the applicator unless the active region of the applicator is fully inserted into target tissue.If the applicator is not properly located into the selected tissue, an unintended thermal injury may occur.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 MICROWAVE TISSUE ABLATION APPLICATOR
• Type of Device: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES,
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• MDR Report Key: 11261482
• MDR Text Key: 230754310
• Report Number: 1317056-2021-00020
• Device Sequence Number: 1
• Product Code: NEY
• Combination Product (y/n): N
• PMA/PMN Number: K162449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 700106003
• Device Lot Number: 5616099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Initial Date Manufacturer Received: 01/24/2021
• Initial Date FDA Received: 02/01/2021
• Supplement Dates Manufacturer Received: 01/24/2021
• Supplement Dates FDA Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1