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

Model Number 700106001-US

Device Problems Loss of or Failure to Bond (1068); Continuous Firing (1123); Crack (1135); No Display/Image (1183); Failure to Deliver Energy (1211); Flaked (1246); Fluid/Blood Leak (1250); Fracture (1260); Material Fragmentation (1261); Leak/Splash (1354); Poor Quality Image (1408); Energy Output Problem (1431); Output above Specifications (1432); Pitted (1460); Device Remains Activated (1525); Use of Device Problem (1670); Dull, Blunt (2407); Misfire (2532); Failure to Fire (2610); Communication or Transmission Problem (2896); Connection Problem (2900); Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907); Failure to Shut Off (2939); Adverse Event Without Identified Device or Use Problem (2993); Output below Specifications (3004); Output Problem (3005); Temperature Problem (3022); Wireless Communication Problem (3283); Component Misassembled (4004); Firing Problem (4011); Unexpected Shutdown (4019); Intermittent Energy Output (4025)

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

Event Date 11/24/2020

Event Type  malfunction  

Manufacturer Narrative

The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

An angiodynamics clinical specialist reported the following: "today during a mwa liver, after two 6 minute 140 watt burns, a third burn was attempted at 4 minutes 140 watts.When the ablation was started we got a high reflective power warning on the generator.The physician tried to reposition the applicator several times and reattempt the ablation but each attempt got a high reflective power warning.I turned the generator off and disconnected the applicator, letting the generator sit for a couple of minutes.The physician asked that i contact (b)(6), the tm, because this had happened before and justin was able to get the generator to proceed, but he was covering another case and i could not reach him.I reached out to tanner tiefenbach for assistance.He advised me to shut the generator off and wait a minute, check the cartridge for any moisture and let the generator go through the self-test before reconnecting the applicator.I did this and it did not work.The applicator position was also checked for proximity to hot previously ablated tissue or positioning in a gas pocket and neither were the reason.I advised that we use a different applicator but the physician was insistent that he did not want to give up his placement.During our troubleshooting, justin arrived with another generator and we tried to use it.This too failed.Again i advised that the applicator is the reason and we should try a different one.The physician agreed and we changed applicators and completed the procedure successfully.When he pulled the troublesome applicator from the patient it had an area of separation but had not broken off.He was watching his ablation with ultrasound and said he saw a burst during the second 6 minute 140 watt ablation but thought it to be a steam pocket.He believes this is the time when the applicator problem occurred but was able to complete the ablation in progress.The physician said that the high reflective power has occurred several times prior to this one.The patient was under general anesthesia and the case was delayed more than 30 minutes for troubleshooting." the patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.

Manufacturer Narrative

Returned for evaluation was one solero probe.As received, the probe ceramic tip was partially detached from the shaft.Functional testing could not be performed due to the condition of the returned device.There was a gap of <1mm between the shaft and the ceramic tip which exposed the copper of the semi-rigid.There are dark marks on the outside of the ceramic tip that are likely from a high energy release.Signs of heat related darkening is evident.The cause of the tip charring has not been identified.The customer's reported complaint description of probe tip separated from shaft is confirmed; gap present between ceramic tip and shaft.The root cause for the malfunction cannot be determined.Review of the device history review was performed for the applicator lot any deviation in manufacturing process related to the reported defect of the complaint.Dhr review of the packaging and component lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.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.Inspect the solero applicator's pre-attached tubing sets prior to use.Do not use the device if the tubing sets have any evidence of damage (e.G.Kinks, cracks, etc.).Obtain a minimum of 1000 ml of sterile chilled saline.3000 ml chilled saline may also be used to increase the amount of time before the cooling reservoir needs to be replaced.Sterile fluid should be chilled prior to procedure.To attach the single use tubing to a chilled-fluid delivery and collection system, remove the cap on tubing set spike and insert spike in the saline source, being careful not to puncture through the saline source.To ensure proper fluid movement hang the saline source higher than the generator (such as on an iv pole).Load the tubing set into the solero generator pump.The pump clip on tubing should be loaded into the pump clip holder on the left side of the pump and then close the pump housing cover.Prime the tubing set by turning the pump on and making sure there are no air bubbles present in the tubing set and in the saline bag prior to placing the device in the target tissue." 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: 11029125
• MDR Text Key: 225592687
• Report Number: 1317056-2020-00214
• Device Sequence Number: 1
• Product Code: NEY
• UDI-Device Identifier: H787700106001US0
• UDI-Public: H787700106001US0
• Combination Product (y/n): N
• PMA/PMN Number: K162449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 700106001-US
• Device Catalogue Number: 700106001US
• Device Lot Number: 5646314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1