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

Model Number 12740000

Device Problems Failure to Deliver Energy (1211); Energy Output Problem (1431)

Patient Problems Hemorrhage/Bleeding (1888); Hyperemia (1904)

Event Date 01/06/2022

Event Type  Injury  

Manufacturer Narrative

The reported solero unit has yet to be returned to the manufacturer for an evaluation.The results of the investigation will be sent via a follow up medwatch.Reference #: (b)(4).

Event Description

A distributor, nipro, reported to an angiodynamics international sales director of an issue with a solero mta generator that resulted in an adverse patient event.The patient was referred by his treating physician to this facility for a mwa of hepatocarcinoma, as one of his last treatment options.The mwa procedure was initially performed as planned with nipro medical staff assisting.Ultrasound-guided puncture of the liver was performed using a 14cm solero applicator and it was positioned in the hepatic nodule without major difficulty.When the nipro medical staff was asked to activate the delivery of microwave energy, it happened that the microwave equipment did not work and sent an hrp error message.The needle did not produce heat and could not perform cauterization of the path.A telephone call was made to the angiodynamics expert abroad who indicated several actions to solve the problem, but without success.It was assumed that it was a problem with the microwave needle, so a new needle, 19cm, was ordered.When the second applicator arrived, a second puncture of the hepatic nucleus was performed (without removing the first needle due to the risk of bleeding), but it did not work either.Due to the time elapsed and the fact that all ablation possibilities were exhausted, it was decided to suspend the treatment.The problem was the risk of hepatic bleeding when the applicators were removed.Therefore, it was decided to perform left hepatic artery profilactive embolization which was successfully performed using gelfoam.Both needles were carefully removed and gelfoam was injected into the hepatic surface using a chiba needle.The patient was stable up to that moment, with no signs of hepatic bleeding, he went to recovery at 16.00 hours.Post procedure, it was reported the patient while in recovery was lucid, calm, conversational, painless.However, several control abdominal ultrasound scans were performed, and it was seen that free fluid appeared at subhepatic level (hemoperitoneum).At 17:00 hours it was observed that the volume of the liquid increased progressively (approximately 500 cc at that time).Immediate inter-consultation to emergency surgery and icu was performed.In recovery, the treating staff held an urgent medical meeting with these specialties, and it was decided to perform emergency surgery due to liver bleeding.A conversation was held with the family and the facts were explained as they happened, that is to say that there was a failure of the mwa equipment which never functioned.The wife authorized the surgery.Patient was admitted to sop at approximately 21:00 hours, active bleeding was confirmed and the hepatic bleeding was successfully stopped.After surgery, the patient was transferred to icu where he presented decompensation of liver cirrhosis due to all the medical events suffered by the patient.In icu initially patient was somewhat unstable, but is evolving favorably so far.There are no longer signs of active hepatic bleeding.The patient was discharged home a few days later.

Manufacturer Narrative

The unit was evaluated in the field by the distributor with angiodynamic field service engineer's assistance during a video call.During the video call with the distributor, the high reflected power error was confirmed.Additional testing of the unit determined the unit required calibration.The reported complaint description is confirmed for the high reflective power and wrong wattage.The reported complaint of patient injury could not be confirmed based on the nature of the reported adverse event.During a video call between the distributor and angiodynamics field service engineer, high reflective power was observed.After cleaning the pins with electronic cleaner, the hrp was resolved.The unit then displayed an out of specification power level (low) and requires the unit to be calibrated.The root cause for the high reflective power was determined to be caused by dirty contact pins with the solero probe.The root cause for the wrong wattage/low power output could be due to the unit requiring a recalibration.A review of the device history records (service order history) was performed for the reported serial number (b)(6) for any deviations related to the reported failure mode of the complaint.The review confirmed that the unit met all material, assembly, and performance specification prior to distribution; i.E.No ncr associated with reported failure mode.Labeling review: wrong wattage: the user manual, which is supplied to the user with this unit contains the following statements: the instructions for use, which is supplied to the user with the solero applicators contains the following statement; "caution: under normal system operation, the output power may not reach the power setpoint due to tissue desiccation and the subsequent increase in reflected power.The power output (4) displays the "actual power" which is the difference between the instantaneous forward power and the instantaneous reflected power.As the ablation progresses, the forward power will remain nominally constant around the setpoint, but the reflected power will gradually increase.So, for a typical ablation, the power output display will initially be close to the setpoint but decrease as the tissue desiccates." high reflected power: 6.2.5 high reflected power the system will display a warning when the reflected power exceeds a preset threshold as shown and abort the ablation.If this occurs, microwave energy is unable to be effectively transferred from the applicator tip into the targeted tissue due to desiccation.Further progress is blocked until the warning is acknowledged.If a "high reflected power" condition is indicated, several sources are possible and warning message will be displayed as shown.The following are several possible sources leading to the "high reflected power" condition: · the applicators active region may not be fully inserted into the tissue or a transient gas pocket may have formed around the applicator tip.Adjust the positioning of the applicator.Adjust time as necessary.Press start/stop button to restart the ablation.· connection to the generator may have been lost.Check the connection to the generator.Adjust time as necessary.Press the start/stop button to restart the ablation.· the applicator may be defective.Replace the applicator with a new one.· if the problem persists, contact angiodynamics inc.For technical support." a review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.Reference (b)(4).

• Brand Name: SOLERO MICROWAVE TISSUE ABLATION SYSTEM
• 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: 13499113
• MDR Text Key: 289739007
• Report Number: 1317056-2022-00024
• 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: User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 12740000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male