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

Catalog Number	700106003
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/08/2023
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 territory manager, who was in attendance for the procedure, reported an issue with a 29cm solero applicator.The applicator was not tested prior to the procedure.The tm had set the unit for 140w for six minutes.The procedure was performed laparoscopically.The doctor used a metal "tunneler" to tunnel to the liver, and then inserted the applicator through the metal device with some difficulty.It was reported that he kept inserting and withdrawing the applicator to line it up with the area he wanted to burn.He performed three burns, withdrawing it each time to reposition it, but no examination of the tip was done at those times.She said that he would "poke around" inside the patient each time he withdrew the applicator.He also asked her to restart the time to six minutes regardless of how much time remained on the unit.This would add another 6 minutes to the amount of burn time he had already used.She was unable to provide the exact total amount of time that they ended up using.She suggested several times to exchange the applicator, however those suggestions were disregarded.When he withdrew the metal "tunneler" she said it looked bent.She said after multiple burns, an hrp error message was received, at which time she again suggested he switch to a new applicator.It was also noted that he was handling/manipulating the applicator very roughly during the procedure.When he withdrew the applicator at the close of the procedure was when it was noted the tip had detached inside the liver.They x-rayed the patient, found exactly where the tip was and were able to retrieve the entire probe tip.Since they were already in the or, it was not necessary to take the patient to the or for removal.They matched what was removed to the probe outside and it matched up perfectly.They re-scanned the patient and nothing was left behind.The doctor has been using solero product for several years.
Additional Manufacturer Narrative
As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of ceramic tip detached and high reflected power (hrp) warning message cannot be confirmed.No probe complaint sample was returned for evaluation.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.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 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
• 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: 17765993
• Report Number: 1317056-2023-00125
• Device Sequence Number: 7093809
• Product Code: NEY
• UDI-Device Identifier: H787700106003US0
• UDI-Public: H787700106003US0
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2023

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: 07/31/2025
• Device Catalogue Number: 700106003
• Device Lot Number: 5789725
• 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: 09/08/2023
• Supplement Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2023
• 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 Age: 65 YR
• Patient Sex: Male