MAUDE Adverse Event Report: ANGIODYNAMICS, INC NANOKNIFE 15CM IRE SINGLE ELECTRODE

Catalog Number H787204001040

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

Patient Problem Arrhythmia (1721)

Event Date 06/05/2019

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 investigation will be sent via a follow up medwatch.Complaint # (b)(4).

Event Description

This medwatch is not to report a device malfunction, but to report an adverse patient effect.During ire energy delivery to liver, patient developed svt.Energy delivery was paused and chemical cardioversion was attempted.Ire energy delivery was resumed.At the end of ire energy delivery, the svt persisted.Electrical cardioversion was again attempted.The patient was admitted for 2 days post procedure for cardiology monitoring and follow-up.The patient has been reported as stable.It was reported the defective disposable device is not available for return to the manufacturer as it was disposed of by the user.

Manufacturer Narrative

As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.As a device evaluation was not performed, a root cause for the event cannot be established.The customer's reported complaint of patient cardiac complications (svt) cannot be confirmed given the nature of the adverse event.There was no reported issue with the function of the nanoknife (nk) generator or probes during the procedure.Root cause of the cardiac complication cannot be definitively determined but is likely a result of the nk procedure in question.Svt is listed in the directions for use as a potential adverse event of the nanoknife system.Dhr review was not conducted since there was no reported probe lot # and ship history lot review was not performed since probe item # is unknown.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".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 15CM IRE SINGLE ELECTRODE
• Type of Device: NANOKNIFE 15CM IRE SINGLE ELECTRODE
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 8784791
• MDR Text Key: 150835764
• Report Number: 1319211-2019-00064
• Device Sequence Number: 1
• Product Code: OAB
• UDI-Device Identifier: H787204001040
• UDI-Public: H787204001040
• 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,u
• Type of Report: Initial,Followup
• Report Date: 08/07/2019

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: H787204001040
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/14/2019
• Initial Date FDA Received: 07/12/2019
• Supplement Dates Manufacturer Received: 06/14/2019
• Supplement Dates FDA Received: 08/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization