MAUDE Adverse Event Report: ANGIODYNAMICS, INC NANOKNIFE SINGLE ELECTRODE PROBE, 15CM; IRREVERSIBLE ELECTROPORATION SYSTEM

Catalog Number UNKNOWN

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

Patient Problem Reaction (2414)

Event Date 12/13/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that the disposable device is not available to be returned to the manufacturer for evaluation.An investigation into the root cause of this incident is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.Complaint reference (b)(4).

Event Description

This medwatch is not to report a device malfunction, but to report an adverse patient effect.A (b)(6) female patient presented for an ire procedure of the liver.The procedure was performed using five nanoknife needles (ct- guided).During the procedure there was discharge on the skin surface.It was reported by the treating physician that the placement of the needles was perfect (10 cm in the "deepth" up from the skin and distances about 1,5 cm between the needles.At the close of the procedure, air pockets were noted in the subcutaneous tissue.The patient was reported as stable post procedure.It was reported that the disposable device is not available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

Device evaluation: as the nanoknife probes used during the reported event were not returned, angiodynamics was unable to perform a device evaluation.The end user provided angiodynamics with a video showing pulses being delivered and the needle placement.An image of the needle placement was also provided.The customer's complaint description cannot be confirmed based on the video and image provided.Additionally, due to the nature of this complaint, functional testing of a returned sample would not duplicate the issue due to the root cause being a patient issue.There was no report of device malfunction or performance problems.Disposable probe review: a device history review of the disposable needles could not be performed as the item number and lot number of the needles was not provided.Hardware review: a review of the accounts hardware service records for the reported nanoknife generator (sn (b)(4)) noted no issues, servicing, repairs or upgrades around the time of this complaint.Labeling review: the instructions for use, which is supplied to the end user, 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".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.Complaint reference (b)(4).

• Brand Name: NANOKNIFE SINGLE ELECTRODE PROBE, 15CM
• Type of Device: IRREVERSIBLE ELECTROPORATION SYSTEM
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 8239808
• MDR Text Key: 132796538
• Report Number: 1319211-2019-00001
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K080287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• 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
• Date Manufacturer Received: 12/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR