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 Tissue Breakdown (2681)

Event Date 12/14/2020

Event Type  Injury  

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 reported defective device was not returned, angiodynamics is unable to perform a device evaluation.The reported event of patient injury cannot be confirmed given the nature of the patient's adverse event.There was no reported issue with the function of the nanoknife during the procedure.Hardware review: this disposable device does have a related angiodynamics hardware unit, however, the serial number of the unit was not reported.A review of the hardware database system is not required.A device history records 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.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.(b)(4).

Event Description

This medwatch is not to report a device malfunction, but to report an adverse patient effect.An angiodynamics sr.Vp of clinical affairs reported a journal article that was published december 05, 2020 titled "ureteric injury after image-guided ablation of renal cell cancer with irreversible electroporation".In the "journal of vascular and interventional radiology".The article was based on a case in which a nanoknife system was used.Refer to the attached article for full details, however a brief summary is as follows: a case is presented ofureteric injury after ire of a renal cell carcinoma (rcc) adjacent to the left ureter, which was managed conservatively with retrograde ureteric stent placement.The patient was prepped and presented as per normal provider protocol.The procedure was started using 6 ire electrodes placed at the peripheral margin of the rcc.1 of the electrodes was placed in proximity of the lateral wall of the left ureter (fig 2b in the attached article), which was unplanned but thought to be acceptable.Pulses were delivered.During the treatment, the ire generator had an electrical current surge owing to high voltage secondary to an equipment issue, but the patient experienced no immediate complication.The patient was monitored after the ire procedure for 2 hours and was transferred to the regular ward.The patient was discharged home the next day with a 10-day course of oral ciprofloxacin.His renal function was stable.Contrast-enhanced magnetic resonance (mr) imaging performed 1 month after ire demonstrated new moderate left hydronephrosis with a blood clot in the renal pelvis, and there was contrast extravasation from the left proximal ureter adjacent to the treated zone of ablation (fig 3a, b).Contrast material was seen passing through the ureter downstream from the point of extravasation suggesting that the left ureter was patent.The patient's renal function remained stable.A retrograde ureteric stent was inserted under general anesthesia to allow healing of the left proximal ureter.Contrastenhanced mr imaging performed 3 months after ire with the ureteric stent in situ continued to show shrinkage of the zone of ablation, and no evidence of local recurrent disease.There was no evidence of leakage around the ureteric stent, and the patient was otherwise well.Contrast-enhanced mr imaging of the abdomen performed 6 months after ire and 3 months after stent removal showed no evidence of local recurrent disease but recurrent moderate left hydronephrosis, which was likely secondary to the proximal ureteric stricture at the site of leakage (fig 4).This required reinsertion of a stent by a retrograde approach for long-term management; the ureteric stricture was confirmed at utereteroscopy.The patient's renal function had improved following reinsertion of the ureteric stent.The patient died 12 months after treatment of an unexpected cardiac event.The article's summary (closing paragraph) is as follows: the ureteric injury was likely caused by the electrical current surge from the generator, leading to thermal injury.Despite the safe profile of ire, it is prudent to avoid placing the electrode immediately next to the ureter, and retrograde ureteric stent placement is required before ire to reduce the risk of complication.

• 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
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 11087152
• MDR Text Key: 224079940
• Report Number: 1317056-2020-00223
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K080287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2020

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: UKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 12/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 74 YR