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

Catalog Number H787204001070

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

Patient Problems Necrosis (1971); Pain (1994); Patient Problem/Medical Problem (2688)

Event Date 04/13/2018

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 device evaluation will be sent via a follow up medwatch.(b)(4).

Event Description

As reported to angiodynamics on november 02, 2017: this medwatch is not to report a device malfunction, but to report an adverse patient effect."ct guided ire liver lesion with close approximation to the right portal vein.The post ablation ct reveals a complete coverage of the lesion and open portal vein.Three (3) days after the ablation, the patient presented at the emergency room with pain in the ruq.Ct scan of the liver revealed large necrotic area in segment 5/8 of the liver.Occlusion of the portal vein branch to segment 5/8 (next to the ablation zone) was noted.During the procedure, angiodynamics' clinical specialist (that was observing the case), reported he had asked the treating physician about the distance of the needle to the portal vein.The physician reported the distance was even inside the portal vein.The clinical specialist mentioned to the physician that for safety reasons, it would be advisable to try to reposition it at least 5 mm from the portal vein.The physician repositioned the needle as much as possible, due to anatomy and tumor positioning.The clinical specialist can state with exactitude at which distance the needle was repositioned, but most likely it was less than 5 mm.It was reported the technical part of the procedure went very well.The nanoknife and electrodes worked properly.It was reported the disposable device is not available for return to the manufacturer for a device evaluation.

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 there was no device malfunction, the ire probes and nanoknife system used during the reported procedure were not returned for evaluation.The customer's reported complaint of the patient experiencing pain and a necrotic area after the procedure 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.Disposable probe review: in lieu of a lot number, a ship history report (shr) was generated for item description (15 cm ire single electrode, packaged good) in order to ascertain the last three lots of the nanoknife probes shipped to the reporting customer in the six months prior to the procedure date.The shr indicates the account did not receive any nanoknife probes within that time.A review of the lot history records cannot be performed.The instructions for use, which is supplied to the end user with this catalog number, 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".Hardware review: a review of the accounts hardware service records for the reported nanoknife generator (sn (b)(4)) noted no issues, servicing, repairs or upgrades around the time of this complaint.The most recent servicing was for preventative maintenance in january 2018.The user manual for the associated 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.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: 7518020
• MDR Text Key: 108373051
• Report Number: 1319211-2018-00049
• Device Sequence Number: 1
• Product Code: OAB
• UDI-Device Identifier: H787204001070
• UDI-Public: H787204001070
• 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
• Type of Report: Initial,Followup
• Report Date: 06/27/2018

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: H787204001070
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/20/2018
• Initial Date FDA Received: 05/16/2018
• Supplement Dates Manufacturer Received: 04/20/2018
• Supplement Dates FDA Received: 06/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization