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

Catalog Number UNKNOWN

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

Patient Problem Aneurysm (1708)

Event Date 05/19/2021

Event Type  Death  

Manufacturer Narrative

The reported device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

An angiodynamics clinical specialist reported the following: "dr.(b)(6) treated this patient's pancreatic tumor on (b)(6) 2021 with nanoknife.A nanoknife 3.0 was used, and it was reported the probes were 15cm.This was his first case.Ct imaging was not indicative of the extent of disease and it was not until he had opened the patient and visualized with ultrasound that he discovered the tumor was more involved than previously thought and he would not be able to treat margins and resect.He decided to proceed with ire for unresectable tumor.The patient did have a metallic stent present, and it was advised best case to remove it and if not, it could be treated with possibility of some untreated tissue being left behind because of the presence of the stent.It was also advised that the probes must be at least 1cm from the stent and the stent could not be inside of the ablation zone, the probes could not bracket the stent.The treatment was carried out using 5 probes and it was ensured on ultrasound that the probes were 1cm away from the stent.The stent was not within the ablation zone.We did an initial treatment and 2 pull back treatments to cover the area of the tumor.On the initial treatment we did encounter a high current warning with 2 probe pairs, these 2 pairs were deleted from the treatment plan and we carried out the rest of the initial treatment and then did troubleshooting to rid the high current warning for those 2 pairs prior and treated those 2 by themselves prior to the first pullback.He did not want to decrease exposure first, so we went with the next step of decreasing the pulse length to 70.This did not work so the voltage was decreased and we did not encounter the high current warning again in this treatment.We did do 2 rounds of 90 on most probe pairs to try to reach a delta of 12-15.On the first pullback the parameters determined from the initial treatment remained unchanged and we received 1 high current warning and proceeded as the initial treatment, taking that pair out and completing treatment of the first pullback then troubleshooting the high current probe pair and treating only this one.In pullback 1 we only retreated 3 probe pairs another 90 pulses to try to reach a delta of 12-15.On pullback 2 we did not receive any high current warnings and did a second round of 90 on 3 probe pairs.At the following week's case with dr.(b)(6), i asked about this patient's status and he said he had placed a pancreatic drain in surgery the day of treatment for a pancreatic leak and had left it in place.The patient had remained in the hospital with the drain and was finally discharged home with the drain in place.Today, (b)(6) 2021, on a peer-to-peer call with dr.(b)(6) regarding the first two cases and planning for the third case i found out from dr.(b)(6) that the patient had passed away.It was asked of dr.(b)(6) if he believed that nanoknife was the cause for the outcome, and he said yes.He said the patient had possibly developed a gastroduodenal artery aneurysm and came into the hospital bleeding.According to dr.(b)(6) this outcome was almost one month post ire.He was also wanted dr.(b)(6)'s input on this case and the outcome.On the call both physicians discussed the case and ire treatment with the stent in place.It was indicated that the reported device is not available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint of vessel perforation cannot be confirmed given the nature of this patient adverse event.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.A dhr review was not conducted since there was no reported probe lot number and ship history lot review was not performed since probe item number is unknown.Hardware review: the serial number of the hardware unit used during this event was not reported by the complainant.A review of the hardware service records is not required.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; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• MDR Report Key: 11900466
• MDR Text Key: 253129896
• Report Number: 1317056-2021-00112
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• PMA/PMN Number: K080287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• 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: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 65 YR