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

Catalog Number UNKNOWN

Device Problem Energy Output Problem (1431)

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

Event Date 12/28/2021

Event Type  malfunction  

Manufacturer Narrative

As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description cannot be confirmed as the device was not returned for evaluation.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.The end user did not provide any identifying product code or lot number., therefore, no dhr review was able to be conducted.A ship history report (shr) for customer for the past 6 months shows more than one size of solero probe shipped to them (14cm and 19cm).A dhr review of shr lots is not warranted as the size of solero probe used is unknown.Labeling review: the instructions for use, which is supplied to the user with microwave probes, contains the following statements: 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).Reference (b)(4) for the first associated solero applicator.

Event Description

2nd applicator: a clinical specialist reported an end user experienced an issue when using a solero applicator.The first solero probe was connected and without testing outside the patient, it was inserted into the patient's liver tissue approximately 6 seconds into the ablation, a "high reflective power" error came up.They tried repositioning probe, disconnecting the cartridge, shutting down machine and rebooting it with no resolution.The cs provided virtual support after the procedure had already started.At the time of the support, the settings on the unit was 100w at 4 minutes.The physician stated their was no force or bending of the applicator upon placement, and when withdrawn there was no sign of damage.It was determined to switch applicators after two attempts to resolve the hrp.A second probe was opened and testing it in saline resulted in the same outcome of an hrp.After many failed attempts, the foot pedal was disconnected, and the ablation was able to be successfully performed.The procedure was completed with the second applicator.The applicators were both disposed of at the conclusion of the procedure.The cs suspected part of the reason for the event was due to the nurse not allowing the pump to prime completely before the ablation for each applicator used.The patient did not experience any adverse effects, harm, or require medical intervention because of this incident, however, the procedure was prolonged for greater than 30 minutes due to this event, at which time the patient was sedated.This event meets the criteria a reportable adverse event; patient safety risk due to prolonged procedure greater than 30 minutes (extended sedation).

• 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: 13235367
• MDR Text Key: 283673891
• Report Number: 1317056-2022-00007
• Device Sequence Number: 1
• Product Code: NEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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