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

Model Number 203003010

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

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 04/09/2021

Event Type  Death  

Manufacturer Narrative

The associated nanoknife unit will not be returned for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

A distributor reported a patient death, following a procedure with this nanoknife generator.On (b)(6) 2021, an ire pancreas case was performed tc and guided percutaneously with 3 needles.The patient's tumor measured: 1.5 x * 1.7 x 3.0 cm.An ivy ecg sync was used during the procedure.The procedure was completed with no issues and a post ct scan did not show any complications, such as bleeding or thrombus.The patient was monitored continuously; however, the patient expired on the morning of (b)(6) 2021, as the result of a heart attack.The patient had no prior history of cardiac issues and the clinicians do not consider the ire procedure to be correlated, in any way, to the death of the patient.The death is believed to be just an unexpected event.The associated nanoknife generator will not be returned to the manufacturer for evaluation as there was no allegation of malfunction or contribution to the patient death.

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 nanoknife generator (serial number: (b)(6) was not returned, angiodynamics is unable to perform a device evaluation.The nanoknife generator was not returned for evaluation since there was no report of unit malfunction during the procedure.The customer's reported complaint could not be confirmed given the nature of the patient serious adverse event (sae, cardiac complications).Without receiving product to evaluate, we cannot determine if any non-conformance was present in the probe/generator.Per the treating physician, the cause of death was an unexpected cardiac event that was not related to the ire procedure.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.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: 11715609
• MDR Text Key: 246973765
• Report Number: 1319211-2021-00028
• 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: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 203003010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 77 YR