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 Fistula (1862)

Event Date 04/28/2023

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.No nanoknife probe product was returned to angiodynamics for evaluation since there was no reported nanoknife system malfunction during the procedure.The customer's reported complaint description of patient serious adverse event (i.E.Prostatic rectal fistula) cannot be confirmed given the patient centric nature of this event.No nanoknife probe devices were returned for evaluation since there was no reported complaint nanoknife system malfunction during the procedure.No dhr review was not conducted since there was no reported lot # and ship history report lot review was not performed since item # is unknown.In addition, there was no reported malfunction of the nanoknife probe/generator during the procedure 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)." hardware unit review: the serial number of the hardware unit used during this event was not reported by the complainant.A review of the hardware service order history records cannot be performed.In addition, this customer account did not request a service order (complaint) for their hardware unit at the time of this patient issue.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).

Event Description

This medwatch is not to report a device malfunction, but to report an adverse patient effect.A physician reported that post patient's nanoknife procedure, the patient experienced procedural complication of prostatic rectal fistula.The following information was reported: the patient received ire treatment for localized prostate cancer; left side of gland.Upon active surveillance and assessment, an out of field new lesion was noted in patient's right posterior peripheral zone.5 ire electrodes placed for subtotal hemiablation on patient's right side of gland.8 total treatment pairs.Hydro dissection in between prostate and rectum completed to provide additional safety margin.Energy was delivered within defined parameters.1 electrode was repositioned to extend treatment margin to posterior midline to ensure adequate ablative volume on clinician's discretion.2 additional probe pairs treated.It was reported that there were no device malfunctions or patient complications during the procedure.# weeks post procedure, the physician the patient presented with a procedural complication of prostatic rectal fistula.Patient to see urologic reconstruction surgeon for consult of surgical correction.The outcome of that consult was placement of a suprapubic catheter and potential surgical reconstruction.

• 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
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 17201609
• MDR Text Key: 317941172
• Report Number: 1317056-2023-00055
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2023
• 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 Sex: Male