MAUDE Adverse Event Report: ANGIODYNAMICS NANOKNIFE SYSTEM; LOW ENERGY DIRECT CURRENT ABLATION SYSTEM,,

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Paresis (1998); Movement Disorder (4412)

Event Date 11/16/2020

Event Type  Injury  

Manufacturer Narrative

It was reported that the disposable 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 Description

A physician reported a patient issue, following a successful ire liver procedure with no reported patient complications or device malfunctions.It was reported the patient was very slim and had a previously paced port placed on his right side.Post treatment, anesthesia reported that the patient was stable in the recovery room; however, later that evening, the patient developed an isolated, right arm palsy.A ct and mri were performed and previously unknown brain metastases was discovered.It is believed that the metastases has been there for a long time.Neurologists are assuming that the right arm palsy is due to damage of the plexus.The position of the patient over the length of the procedure and setup may be the cause'; however, it is currently undetermined.Additional information reported (approximately two weeks post procedure) that the patient no longer was experiencing the reported palsy and the patient was doing well.General anesthesiological treatment with infusion, opiate or wound healing mechanisms of patient body with relaxing time on day by day was provided as treatment for the palsy.It was reported that there were no device malfunctions during the procedure.It was indicated that the reported device is not available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

This medwatch is not to report a device malfunction, but to report an adverse patient effect post procedure.There was no report of a device malfunction or patient complication during the procedure.As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description cannot be confirmed given the nature of the patient serious adverse event.There were no reports of nanoknife probe or generator malfunction observed during the procedure.Ablation of liver was uneventful.The root cause of the patient post-op complication of right arm palsy is likely related to the patient's slim body structure and their positioning on the procedure table.The surgeon provided feedback that he has not seen this before but anesthetists see it more often.Dhr review was not conducted since there was no reported probe lot # and ship history lot review was not performed since probe item number is unknown.Labeling review: the instructions for use which is supplied to the end use, states: "warnings: do not use a device with damaged insulation.Do not attach anything to the device unless it is supplied by angiodynamics and indicated for use with this device.Attachments may damage the insulation and contribute to patient injury.Adverse effects that may be associated with the use of the nanoknife system include, but are not limited to: arrhythmia, atrial, fibrillation or flutter, bigeminy, bradycardia, heart block or atrioventricular block, paroxysmal supraventricular tachycardia, tachycardia, reflex tachycardia, ventricular tachycardia, ventricular fibrillation, fistula formation, damage to critical anatomical structure (nerve, vessel, duct), hematoma, hemorrhage, hemothorax, infection, muscle contraction pneumothorax , reflex hypertension, unintended mechanical perforation, vagal stimulation, asystole and venous thrombosis".The user manual for the nanoknife generator, states: electrodes that are not parallel to each other may result in an incomplete ablation.Inappropriately positioned electrodes or metal implants in the field may distort the desired ablation field.Avoid unnecessarily high voltage or excessive number of pulses.Avoid short-circuiting the electrodes when delivering pulses.Electrode to electrode contact or electrode to electrode spacing less than 5 mm (millimeters) may result in short circuiting during energy delivery resulting in incomplete ablation.Adverse effects that may be associated with the use of the nanoknife system include, but are not limited to the following: arrhythmia, pneumothorax, muscle contraction, hemorrhage, unintended mechanical perforation, infection, bradycardia, vagal stimulation, asystole, damage to critical anatomical structure (nerve, vessel, and/or duct)." 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: NANOKNIFE SYSTEM
• Type of Device: LOW ENERGY DIRECT CURRENT ABLATION SYSTEM,,
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 10930083
• MDR Text Key: 219136955
• Report Number: 1319211-2020-00086
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• PMA/PMN Number: K080287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/01/2020
• Supplement Dates Manufacturer Received: 11/17/2020
• Supplement Dates FDA Received: 12/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR