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

Catalog Number 20400104

Device Problem Arcing of Electrodes (2289)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2023

Event Type  malfunction  

Event Description

1st device: an end user reported an issue with two 15 cm ire single electrode needles.During a procedure, when the needles were outside of the patient, a spark between the two needles was observed.There was no evidence of smoke and no burning smell and the procedure was performed following the instructions for use (ifu).The procedure was completed with these needles and the patient, nor physician, experienced any adverse effects, harm, or required medical intervention as a result of this incident.Reportedly, the physician is experienced and is always supported by a clinical specialist from mcm medsys ag.

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).(b)(4).

Event Description

Additional information: ct guided ire of liver percutaneous performed.During pulse delivery (treatment of tumor inside the body), there were some sparks between the isolated part of the 2 needles outside of the patient.The protocol didn´t show any sparks or something else unusual and the procedure went well as usual.No burning on patient/ skin or anywhere else.The patient and procedure outcome wasn´t affected at all.It looked more like arcing.The isolation of the affected needles had no damages (inspected by the distributors clinical).It wasn´t touched with anything sharp (e.G.Tongs) and did not have burning marks or something else.

Manufacturer Narrative

As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of a spark arced between two needles (outside of the patient was not able to be confirmed given the patient centric nature of this incident.No probe complaint samples was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.It was reported that there was no damage to the probe needle insulation tubing observed.No clamps or other devices were connected to needle and no burn marks on needle or injury to the patient.A review of the device history records was performed for the indicated lot for any deviations related to the reported failure mode of the complaint.The review confirms that the lot met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.Labeling review: the instructions for use which is supplied to the end user, 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.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 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.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.Imaging equipment with high definition capabilities is recommended for procedures where a target area involves or is adjacent to critical structures.Having inadequate imaging equipment may result in unintended mechanical perforation, damage to critical anatomical structures, and/or hemorrhage.Adverse effects that may be associated with the use of the nanoknife system include, but are not limited to: arrhythmia.Atrial fibrillation or flutter.Tachycardia.Fistula formation.Damage to critical anatomical structure (nerve, vessel, duct).Hemorrhage.Hardware unit review: a review of the service order system for serial number {01760912} revealed there have been no previous repairs, servicing and/or upgrades for this unit associated with probe spark since the unit was distributed.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).1st device (b)(4) 1317056-2023-00140.2nd device (b)(4) 1317056-2023-00144.

• 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: 17948964
• MDR Text Key: 325828787
• Report Number: 1317056-2023-00140
• Device Sequence Number: 1
• Product Code: OAB
• UDI-Device Identifier: H787204001040
• UDI-Public: H787204001040
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K080287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 20400104
• Device Lot Number: 5793721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2023
• Initial Date FDA Received: 10/17/2023
• Supplement Dates Manufacturer Received: 12/06/2023
• Supplement Dates FDA Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2023
• 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 Age: 66 YR
• Patient Sex: Male
• Patient Weight: 81 KG