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

Model Number 20300101

Device Problems Arcing at Paddles (1032); Loss of or Failure to Bond (1068); Break (1069); Failure to Charge (1085); Computer Software Problem (1112); Continuous Firing (1123); Crack (1135); Material Discolored (1170); No Display/Image (1183); Display or Visual Feedback Problem (1184); Failure to Deliver Energy (1211); Flaked (1246); Fluid/Blood Leak (1250); Fracture (1260); Material Fragmentation (1261); Material Frayed (1262); Labelling, Instructions for Use or Training Problem (1318); Inability to Irrigate (1337); Leak/Splash (1354); Mechanical Problem (1384); Melted (1385); Migration or Expulsion of Device (1395); Poor Quality Image (1408); Delivered as Unsterile Product (1421); Material Opacification (1426); Energy Output Problem (1431); Output above Specifications (1432); Pacing Problem (1439); Unsealed Device Packaging (1444); Pitted (1460); Failure to Power Up (1476); Off-Label Use (1494); Decreased Pump Speed (1500); Increased Pump Speed (1501); Failure to Pump (1502); Pumping Stopped (1503); Material Puncture/Hole (1504); Device Remains Activated (1525); Difficult to Remove (1528); Shipping Damage or Problem (1570); Stretched (1601); Inaccurate Synchronization (1609); Unexpected Therapeutic Results (1631); Use of Device Problem (1670); Insufficient Flow or Under Infusion (2182); Material Perforation (2205); Visual Prompts will not Clear (2281); Device Damaged Prior to Use (2284); Aborted Charge (2288); Arcing of Electrodes (2289); Incomplete or Missing Packaging (2312); Failure to Deliver (2338); Failure to Infuse (2340); Tear, Rip or Hole in Device Packaging (2385); Dull, Blunt (2407); Obstruction of Flow (2423); Failure to Calibrate (2440); Failure to Advance (2524); Misfire (2532); Arcing (2583); Delayed Charge Time (2586); Sparking (2595); Failure to Fire (2610); Battery Problem (2885); Calibration Problem (2890); Charging Problem (2892); Contamination /Decontamination Problem (2895); Communication or Transmission Problem (2896); Connection Problem (2900); Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907); Device Markings/Labelling Problem (2911); Device Misassembled During Manufacturing /Shipping (2912); Device Sensing Problem (2917); Difficult to Advance (2920); Difficult to Open or Remove Packaging Material (2922); Expulsion (2933); Failure of Device to Self-Test (2937); Failure to Auto Stop (2938); Failure to Shut Off (2939); Infusion or Flow Problem (2964); Device Contaminated During Manufacture or Shipping (2969); Manufacturing, Packaging or Shipping Problem (2975); Material Deformation (2976); Material Integrity Problem (2978); Material Twisted/Bent (2981); No Flow (2991); Adverse Event Without Identified Device or Use Problem (2993); Output below Specifications (3004); Output Problem (3005); Packaging Problem (3007); Power Problem (3010); Pumping Problem (3016); Temperature Problem (3022); No Apparent Adverse Event (3189); Insufficient Information (3190); Appropriate Term/Code Not Available (3191); Device Handling Problem (3265); Wireless Communication Problem (3283); Migration (4003); Component Misassembled (4004); Material Too Soft/Flexible (4007); Firing Problem (4011); Complete Loss of Power (4015); Intermittent Loss of Power (4016); Unintended Electrical Shock (4018); Unexpected Shutdown (4019); No Visual Prompts/Feedback (4021); Intermittent Energy Output (4025)

Patient Problem Tissue Breakdown (2681)

Event Date 01/21/2021

Event Type  Injury  

Manufacturer Narrative

The reported nanoknife unit has yet to be returned to the manufacturer for a device evaluation.An investigation into the root causes currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

An end user reported an issue with a nanoknife generator.During an ire procedure, the unit shut down between pairs of electrodes.This occurs when the generator is done with one combination and then shuts down completely, before going on with the next.It was reported that during this procedure, some of the patient's small and large intestines were damaged.The intestinal damage was seen under ct imaging.After the event,.The patient was treated with acute laparotomy and re-laparotomy 2 times over a five day period.The patient was in icu for 4 days.Additional information provided reported the patient had experienced right-sided hemicolectomy with stomi and perforation of the duodenum which was closed with sutures and drained.It was indicated the reported nanoknife generator is available for return to the manufacturer for a device evaluation.

Manufacturer Narrative

Returned for evaluation was nanoknife unit, serial number (b)(6).When attempting to perform functional testing on the unit, the software was unable to be accessed due to password locked.The unit was reset to factory settings in order to override the password setting.Due to the resetting of the software, the reported complaint event was unable to be reproduced.After the factory reset, the unit functioned as intended.The reported complaint description was not confirmed.A root cause for the reported event could not be established.A review of the device history records (service order system) was performed for the reported serial number (b)(6) for any deviations related to the reported defect of the complaint.The review confirmed that the unit met all material, assembly, and performance specification prior to distribution.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).

Manufacturer Narrative

An additional investigation was performed regarding the password reset error message that occurred when servicing the nanoknife unit for the reported complaint description of the unit shutting down during a procedure.It was determined the testing of the unit was unable to be performed without a factory reset even if the password had been provided.The end user password was not required and would not have prevented the need to perform a factory reset.During normal start-up of the nanoknife generator there is no prompt for user password.Upon start-up of the nanoknife generator in question for functional testing at the service depot, a user password dialogue box was displayed, indicating that the on-board software was corrupt.A user password request (pop up dialogue box) indicates that there was a file corruption with the system software.Having the password from the end user would not have given access to system functions.This file corruption may have induced the reported generator malfunction observed by the customer.Software was re-loaded onto the nanoknife generator to correct the file corruption and allow system diagnostic and testing to be completed.Angiodynamics did not attempt to contact the user/owner of the device to retrieve a password since having a user password would not have given access to the system functions.The user password prompt (pop up dialogue box) was the diagnostic indicator that there was a file corruption with the system software.In order to correct the file corruption, the system software needed to be re-loaded to factory settings.The root cause for the reported failure of unit shutting down could not be confirmed/deteremined, however the software issue may have been a contributing factor.

• 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: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 11337282
• MDR Text Key: 232181401
• Report Number: 1319211-2021-00012
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K102329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 20300101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 02/17/2021
• Supplement Dates Manufacturer Received: 02/03/2021; 03/09/2022
• Supplement Dates FDA Received: 03/07/2021; 03/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization; Other
• Patient Age: 82 YR
• Patient Weight: 73 KG