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

Catalog Number UNKNOWN

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

Patient Problem Obstruction/Occlusion (2422)

Event Date 11/09/2018

Event Type  Injury  

Manufacturer Narrative

This medwatch is not to report a device malfunction, but to report an adverse patient effect.There was no report of a device malfunction or patient complication during the procedure.It was reported that the disposable device is not available to be returned to the manufacturer for evaluation.An investigation results 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.There was no report of a device malfunction or patient complication during the procedure.(b)(6) study (nanoknife - pancreatic cases): post-operative course was complicated by an ileus.The patient had return of bowel function on post-op day #6.Her ng tube was removed and she was started on a clear liquid diet with ensure clear supplements.Complaint investigation is warranted since the relationship to the study procedure is related to the device as assessed by the sae.This resulted in medical or surgical intervention to prevent permanent impairment to body structure or function.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 nanoknife probe was not returned, angiodynamics is unable to perform a device evaluation.The reported complaint description of "patient had an ercp and a new stent placed during admission after developing a bile duct obstruction" could not be confirmed without a device evaluation.The root cause for this event cannot be determined.A device history review could not be performed as a catalogue number and a lot number were not provided.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 SYSTEM
• Type of Device: LOW ENERGY DIRECT CURRENT ABLATION SYSTEM,
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 8474753
• MDR Text Key: 140660097
• Report Number: 1319211-2019-00025
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• PMA/PMN Number: K102329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup
• Report Date: 07/29/2019

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/07/2019
• Initial Date FDA Received: 04/02/2019
• Supplement Dates Manufacturer Received: 03/07/2019
• Supplement Dates FDA Received: 07/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention