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

Catalog Number 20300101-US

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

Patient Problem Atrial Fibrillation (1729)

Event Date 10/12/2017

Event Type  Injury  

Manufacturer Narrative

It was reported that the nanoknife system involved in the incident will not be returned to the manufacturer for evaluation as there was no malfunction.The results of the unit evaluation will be sent via a follow up medwatch.This medwatch is not to report a device malfunction, but to report an adverse patient effect.(b)(4).

Event Description

As reported to angiodynamics on (b)(6) 2017: this medwatch is not to report a device malfunction, but to report an adverse patient effect.During a nanoknife procedure of the liver, the treating physician had placed the probes near the patient's heart.When pulsing the probes with electrical voltage, the patient went into afib.The probe had been pulsed approximately 20 times prior to the event.The patient's heart rate was greater than 105.The patient was given a beta blocker iv for the afib, and a second attempt was made using lesser voltage.After 10 pulses, the afib started again.The procedure was aborted.The doctor was delivering chemo directly to the area as well during the procedure as it was a combination therapy procedure.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

This medwatch is not to report a device malfunction, but to report an adverse patient effect.As there was no reported malfunction of the nanoknife system (generator and probe), the associated disposable probes and generator were not returned for evaluation.The customer's reported complaint of the patient experiencing afib could not be confirmed because no sample was returned for evaluation.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.It was reported the patient returned to normal rhthym without further medical intervention.A root cause for the reported complaint description cannot be determined.The ifu lists atrial fibrillation as a potential adverse effect.A review of the lot history records was performed for lot 5188659 for any deviations related to the reported event of the complaint.The review confirmed that the packaging lots and all incoming lot met all material, assembly, and performance specification.The instructions for use, which is supplied to the end user with this catalog number, states: "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.(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
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: law ryan ; 603 queensbury avenue; queensbury, NY 12804 ; 5187424488
• MDR Report Key: 7002889
• MDR Text Key: 91087471
• Report Number: 1319211-2017-00110
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/28/2017

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: Physician
• Device Catalogue Number: 20300101-US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2017
• Initial Date FDA Received: 11/06/2017
• Supplement Dates Manufacturer Received: 10/13/2017
• Supplement Dates FDA Received: 12/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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