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

Model Number 20300101

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

Patient Problem Fistula (1862)

Event Date 11/04/2020

Event Type  Injury  

Manufacturer Narrative

The associated nanoknife unit is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.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.Reference (b)(4).

Event Description

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.An angiodynamics international medical science liaison (oncology & surgery) reported a patient issue, post nanoknife procedure.The patient developed a prostate/rectal fistula after receiving treatment for prostate cancer.The doctor feels that this is not related to a device failure but rather to the procedure.The physician planned to contact peers for advise regarding the best treatment options for the patient but documented that an additional procedure(s) will be needed.The reported nanoknife generator is not available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

This report is being submitted for additional event information and to correct the event date.Reference (b)(4).

Event Description

An angiodynamics international medical science liaison (oncology & surgery) reported a patient issue, post nanoknife procedure.The patient developed a prostate/rectal fistula after receiving treatment for prostate cancer.The doctor feels that this is not related to a device failure but rather to the procedure.The physician planned to contact peers for advise regarding the best treatment options for the patient but documented that an additional procedure(s) will be needed.Additional information received reports the patient has had follow up since this event.He presented with this fistula on (b)(6) 2011.He remained in the hospital for 5 days, where he received a suprapubic urinary catheter, will the patient still has.The fistula was seen on a ct scan, and was also seen by a cytoscopy.Since that time, the patient has received three prostate mri's to observe/follow the fistula.The patient had presented with pain and weight loss approximately 4 weeks after the initial procedure.The patient described the loss of urine via the rectum when attempting to void his badder.The imaging performed showed typical damage to the prostatic tissue with involvement of the rectum wall.There was no malfunctions of the unit or disposable devices and no patient issue during the procedure.

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 nanoknife generator (serial number unknown) was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint could not be confirmed given the nature of the patient serious adverse event (fistula between prostate and rectum).There was no report of nanoknife probe or generator malfunction during the procedure.Without receiving the unit or device to evaluate, we cannot determine if any non-conformance was present in the probe/generator.The root cause of this event cannot be determined, however, fistula formation is cautioned in the directions for use as a potential adverse effect associated with the use of the nanoknife system.No device history records review was conducted since the serial number of the nanoknife generator used during this procedure was not provided.A review of service order system is not applicable since complaint was reported by distributor and not end user facility.Labeling review: the user manual (nanoknife user manual, which is supplied to the user with this unit contains references to the generator's window display regarding the charge function when in use; "charge section controls the voltage on the capacitors and displays the accumulated energy for ablation.The capacitor status indictor displays the level of the capacitor charge and shows, in volts the voltage present on capacitors.When fully charged, the voltage on capacitors is always greater than the pulse amplitude currently set".The manual also contains warning and caution statements in regards to setting the mains values and replacing the mains use: "do not proceed if the generator does not charge and discharge capacitors correctly when acting on the charge or discharge button.After the discharge button is pressed, the voltage indicated by the high voltage capacitors digital indicator must be lower than 70v".The user manual troubleshooting section also contains a reference as to what to do if experiencing an error message "unable to charge/discharge; "possible reason - the system detected a problem during the charge or discharge of the capacitors.Action to take: confirm that the stop button is not engaged.If "new probe selection" button is active, click, then return to "pulse generation screen" to reinitialize and start the ablation over.If the "retreat"/ "do not re-treat" buttons are active, click "do not re-treat", do not save, then follow steps above.If the system is not able to recharge or discharge the capacitors, please call angiodynamics customer service".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).

• Brand Name: NANOKNIFE SYSTEM
• Type of Device: LOW ENERGY DIRECT CURRENT ABLATION SYSTEM
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 11407228
• MDR Text Key: 240022146
• Report Number: 1319211-2021-00016
• Device Sequence Number: 1
• Product Code: OAB
• UDI-Device Identifier: H787203001010
• UDI-Public: H787203001010
• Combination Product (y/n): N
• PMA/PMN Number: K102329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2021

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 Model Number: 20300101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2020
• Initial Date FDA Received: 03/03/2021
• Supplement Dates Manufacturer Received: 03/06/2021; 03/06/2021
• Supplement Dates FDA Received: 03/30/2021; 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR