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

Model Number 20400103

Device Problems Material Discolored (1170); Melted (1385)

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

Event Date 09/23/2021

Event Type  malfunction  

Manufacturer Narrative

The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

A distributor reported an end user experienced an issue with a nanoknife electrode.After opening the probe packaging, but before starting the procedure, physician noticed that the tip of probe is dark, it looked as if its burnt/charred.The probe had not been placed.It was reported the probe was connected to the unit at the time.The procedure had not been started and the probe had not been activated, however the unit was on at the time.The unit was set to burn at 2700v.It was set aside and the procedure was completed with a new of the same device.The patient did not experience any adverse effects, harm, or require medical intervention because of this incident.The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.

Manufacturer Narrative

Returned for evaluation was one nanoknife probe in its original opened package.As received, the probe shaft was slightly bent when removed from the package.The tip of the nano knife probe appeared burnt/discolored.Per the manufacturing engineer for this product, during the manufacturing process, when the insulation is placed onto the device it is aligned with the trocar tip.There is no heat used in the process where it would cause damage after the insulation is installed.Any defects like this would be captured during this assembly process.Likely something outside of the process before packaged or after received by customer caused the damage.The customer's reported complaint description was confirmed as the insulation sleeve at the tip of the probe was observed to be melted/burnt.The root cause is likely from the tip of the insulation being too close to high heat.Angiodynamics is unable to definitively determine when or where the heat was applied to the device to cause the melting of the insulation; either during manufacturing process or end user facility.The root cause of this product damaged event is unknown, however, this is the only reported complaint of this failure mode for the nanoknife 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 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.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.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; 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: 12658577
• MDR Text Key: 277400201
• Report Number: 1319211-2021-00072
• Device Sequence Number: 1
• Product Code: OAB
• UDI-Device Identifier: H787204001030
• UDI-Public: H787204001030
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K080287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 20400103
• Device Catalogue Number: 20400103
• Device Lot Number: 5636580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2021
• 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