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

Catalog Number 700106001

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); 1317056-2022-00054.

Event Description

Device 1 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 14cm solero applicator.As received, no visual defects were noted.Functional testing was performed on the applicator, at which time, a high reflected power (hrp) eror message was immediately displayed.The applicator was disassembled and fluid was noted to be inside the n-type.The customer's reported complaint description is confirmed for high reflected power (hrp) warning message.Root cause was determined to be fluid observed inside of n-type connector, however, root cause of how fluid migrated into n-type could not be definitively determined as no manufacturing non-conformance with boot seal/assembly was observed.There were two solero generators reported to have been used with the probes associated with (b)(4), (b)(4) and (b)(4).They are: (b)(4) (so 37548) for s/n (b)(6): unit evaluation did not confirm high reflected power during testing.(b)(4) (so 37547) for s/n (b)(6): unit evaluation did confirm high reflected power during testing.Solid state generator was replaced.It is not known specifically what combination of probes and generators were tested.The likely root cause for the hrp error messages observed include the fluid in the n-type connector for the probe associated with (b)(4) (underminable) and the solero generator s/n (b)(6) associated with (b)(4) (solid state generator replaced).A review of the applicator 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, item number 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).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 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: 13654600
• MDR Text Key: 289323217
• Report Number: 1317056-2022-00044
• 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: 05/06/2022

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 Expiration Date: 02/29/2024
• Device Catalogue Number: 700106001
• Device Lot Number: 5666849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2021
• 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
• Patient Age: 62 YR
• Patient Sex: Male