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

Model Number	20400103
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	03/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the disposable 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 or Problem Description
A territory manager reported an end user experienced an issue when using a 15 cm ire single electrode rfid activation probe.The patient presented on (b)(6) 2025 for a nanoknife prostate treatment.Bilateral apex 6 electrodes in treatment naïve gland.Caution and care was taken to avoid rectal ablation.The doctor reported a suspected urethrorectal fistula and sent the patient to the er.He suspected it was from the in and out catheterization required.A catheter was left in for 9 days post procedure due to patient having constipation.Failed first discontinuation attempt of urinary catheter.The catheter was left in for one more week.Failed discontinuation again.The patient started in and out self-catheterization on friday on (b)(6) 2025.On (b)(6) 2025, the doctor was notified of urine passing out of rectum.On (b)(6) 2025, the doctor scoped the patient for a visual assessment.The doctor concluded the in and out catheter undermined the prostate and created a hole.On rectal exam the catheter cannot be felt or palpated.The catheter will be left in for 6 weeks then another reassessment will be performed.
Additional Manufacturer Narrative
No nanoknife probe product was returned to angiodynamics for evaluation since there was no reported malfunction or performance issue with the nanoknife system during the procedure.The reported complaint description of patient rectourethral fistula serious adverse event (sae) cannot be confirmed given the patient centric nature of this event.Per event description the physician concluded the in and out catheterization required undermined the prostate and created a hole.On rectal exam the catheter cannot be felt or palpated.The reported fistula serious adverse event is listed in the device directions for use as potential adverse effects that may be associated with the use of the nanoknife system, i.E.Damage to critical anatomical structure (nerve, vessel, duct), and fistula formation.In lieu of a reported lot number, a ship history report (shr) was generated for the reported 15cm nanoknife probe; two upn's were shipped to this customer account: (b)(4), 15 cm ire single electrode rfid activation, packaged good.(b)(4), 5-probe procedure pack-activation, 15cm, ous.Given that it was reported that six (6) nanoknife probes were used in the ire procedure it is likely both upns are in scope, i.E.A 5-pack and a single probe.Dhr review was performed on the two most recent lots for each upn shipped to the reporting customer in the six (6) months prior to the procedure date.A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.The review confirms that the lots met all material, assembly and performance specifications, i.E.No ncr associated with reported failure mode.Labeling review: the directions for use (dfu, 14610477-01) that is supplied with the nanoknife probe contains the following statements: warnings - the nanoknife* single electrode probe should only be used with the angiodynamics nanoknife generator.The physician must read the nanoknife generator user manual thoroughly before operating the nanoknife generator.- avoid having the nanoknife single electrode probes touch when delivering pulses.Ensure that both nanoknife single electrode probe electrodes are fully embedded within the targeted tissue prior to initiating pulse delivery.- do not bend the nanoknife single electrode probe as this may damage the insulation.- 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.Potential adverse effects adverse effects that may be associated with a nanoknife procedure include, but are not limited to: - fistula formation - damage to critical anatomical structure (nerve, vessel, duct) - hemmorrhage - unintended mechanical perforation probe placement warning: placing a single electrode probe without continual image guidance may increase the risk of unintended mechanical perforation, damage to critical anatomical structures, and/or unintended tissue destruction the user manual for the nanoknife generator (16755922-21), states: precautions - 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.- the position of the electrodes should be monitored during pulse delivery to assure that the probe depth is not changing due to tissue reaction.- energy delivery attempts must be terminated after a high current warning during an ablation in anatomical locations in which there are abutting lumens or other critical structures.Continuous attempts to deliver energy during repeated high current warnings during ablations such as these, may result in fistula formation, especially in patients who have had prior radiation therapy or surgery in the immediate zone of ablation.- use of operator-defined parameters increases the risk of ineffective procedures or post-procedure complications, with respect to validated standard procedures.Potential adverse effects adverse effects that may be associated with the use of the nanoknife system include, but are not limited to the following: - fistula formation - damage to critical anatomical structure (nerve, vessel, duct) - hemmorrhage - unintended mechanical perforation 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).Correction: b4.It was originally reported that the udi of the part number was (b)(4), however since it is unknown if the end user used 6 x (b)(4), or 1 x (b)(4) along with a five-pack, (b)(4), the udi has been corrected to unknown.

• Brand Name: NANOKNIFE
• Common Device Name: LOW ENERGY DIRECT CURRENT THERMAL 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: 21884440
• Report Number: 1317056-2025-00115
• Device Sequence Number: 15490485
• Product Code: OAB
• UDI-Device Identifier: H787204001030
• UDI-Public: H787204001030
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K150089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 20400103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male