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

Catalog Number 700106001

Device Problems Material Discolored (1170); Leak/Splash (1354); Energy Output Problem (1431)

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

Event Date 09/22/2022

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).For the second solero applicator associated with this event, reference (b)(4), report 1317056-2022-00124.

Event Description

First applicator a distributor reported an issue with a 14cm solero applicator.It was reported that when the applicator was position in the patient's tumor, a "high reflective power" error message occurred.The applicator was removed from the patient and found to be leaking from the area that the tip meets the needle.It appeared as though there was a burnt circle around the joint.A second applicator of the same lot was opened and attempted to be used, however, the same issue occurred again; high reflected power message.Leak, and burn like appearance of applicator joint.The second applicator was replaced with a third, which functioned as intended, allowing the procedure to be completed.The patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.

Manufacturer Narrative

Returned for evaluation was one (1) used 14cm solero probe.As received there appeared to be a gap between the needle shaft/ceramic tip (tip fracture) and ceramic tip has dark discoloration.During functional testing of this device a high reflected power message was received.The customer's reported complaint description of probe high reflected power (hrp) was confirmed based on evaluation of the returned probe.In addition, the probe tip was observed to be discolored with a fracture of the joint to the shaft.This appears to be a thermal event that melted the center conductor.The root cause of this type of thermal event could not be definitively determined.Also returned were 26 unused/unopened companion samples of the same lot as the reported device.One random sample was chosen, and functional testing was performed.Per the testing of the unused sample, there were no noted issues and the device functioned as intended.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 instructions for use, which is supplied to the user with the solero applicators contains the following statement; "the solero microwave tissue ablation (mta) system and accessories are indicated for the ablation of soft tissue during open procedures.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: 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).For the second solero applicator associated with this event, reference (b)(4), report 1317056-2022-00124.

• 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
• 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: 15554685
• MDR Text Key: 303889572
• Report Number: 1317056-2022-00123
• Device Sequence Number: 1
• Product Code: NEY
• Combination Product (y/n): N
• Reporter Country Code: MT
• PMA/PMN Number: K162449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 700106001
• Device Lot Number: 5691717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2021
• 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