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

Catalog Number 700106002

Device Problems Flaked (1246); Material Fragmentation (1261)

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

Event Date 01/06/2021

Event Type  malfunction  

Manufacturer Narrative

The reported defective 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

An end user reported an issue with this 19cm solero applicator.The lesion was in segment 6 of liver and the intercostal approach was taken.The applicator was placed under real time ultrasound guidance and in mid intercostal space, without even slightest of rub against the rib.After the first ablation was completed and the physician withdrew the applicator to reposition, it was noted that there was damage to the insulation (coating).After removing the antenna from the lesion the outer insulation appeared discoloured and crumpled, which was wiped using a wet gauze and the insulation came out while wiping.No piece of the insulation remained inside the patient.The unit had been set at 140w for 6 minutes.No warning messaged were displayed during activation of the probe.It was activated 2 times and the damage was noted after removal post 2nd ablation.As the hcc was approx 5.0 cm in size a compound ablation was planned with 3 ablation zones.For 1st ablation power of 140w for 6 min was used and for 2nd ablation a power of 140w 4 min was used.However when the antenna was removed after 2nd ablation it appeared discoloured and the surface was crumpled.It was thought a charred tissue was there over it and a wet gauze was used to wipe it, but the outer plastic sheath came out while wiping.So the third ablation was not done and the procedure was abandoned and the same was reported.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

Received for evaluation was a solero probe.As received, the customer returned one solero probe with coating issue.Sample was not cleaned due the customer report of coating issue.The customer's reported complaint description of coating issue on probe tip is confirmed.Peeling of the coating is present on the first 4cm from the distal tip.This is the area with the greatest heat exposure.Degradation of the coating near the distal tip is expected after multiple full power ablations.The coating is used to improve device removal from ablated tissue.Dried tissue will pull on the coating and can cause a peeling.The coating is approved for direct patient contact and is not a risk from a bio-compatibility perspective.Higher up the shaft the coating is intact and well adhered.Our dipping operation uses a primer followed by the silicone coat and then an oven bake.The dipping is done by a robot.The primer dip and silicone dip are part of the same cycle which ensures all parts are primed before coating.The primer is activated by humidity.It is possible to have variation in the humidity that may create jobs with different adhesion levels but this would affect the entire shaft.After dipping the parts rack is moved into an oven which is then started manually.If the parts were not baked the post bake inspection would have failed.Parts are 100% inspected after bake.This peeling at the distal end is not abnormal after use.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 statement; "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: 11182955
• MDR Text Key: 230753038
• Report Number: 1317056-2021-00013
• 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: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 700106002
• Device Lot Number: 5639990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Date Manufacturer Received: 01/12/2021
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 64