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

Catalog Number UNKNOWN

Device Problem Output Problem (3005)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 08/13/2020

Event Type  malfunction  

Manufacturer Narrative

As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description cannot be confirmed, no sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.Dhr review was not conducted since there was no reported probe lot number and ship history lot review was not performed since probe item number is unknown.No dhr review was not conducted since there was no reported lot # and ship history lot review was not performed since item # is unknown.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".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.Complaint reference (b)(4).

Event Description

An angiodynamics territory manager reported an issue with nanoknife probes.During a procedure, "high current" warnings occurred with 6 out of the 10 probe pairs, used during the ablation.All troubleshooting proved to be ineffective to resolve the issue.The case was concluded without the patient receiving a complete ablation.It was indicated that the reported device is not available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

The customer determined to not return the reported rfa unit for evaluation and repair.As the reported defective rfa unit was not returned, angiodynamics is unable to perform a unit evaluation.The reported complaint description is not confirmed because the unit was not returned for evaluation.The customer indicated the unit was functioning as intended.The root cause for the temperature fault could not be determined because the unit was not returned for evaluation/service.This is the first reported error of this unit for temperature fault.A review of the device history records (service order system) was performed for the reported serial number a112723 for any deviations related to the reported defect of the complaint.The review confirmed that the unit met all material, assembly, and performance specification prior to distribution.Labeling review: the user manual, which is supplied to the user with this unit contains the following statements: ""device temperatures (°c)" display.Displays the temperature readings of the device thermocouples in whole units of °c.For temperatures out of range the display will either read "lo" or "hi".Also, if using a device with fewer than five thermocouples, the locations with no thermocouple will display "op".If the device is not connected, the temperature displays remain blank."device temperatures (°c)" buttons and led's.Each device temperature display has an accompanying button with a number on it and a green led.Pressing the button switches the led on and off.When the led is on, the reading of that temperature sensor is used in the temperature control algorithm.If the led is off, the displayed value is not used in the calculation of the average device temperature.The last display cannot be deselected in atc mode.The displays that indicate "op" prior to the activation of rf energy are excluded from the temperature algorithm in atc mode and their led's are off." 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: 10453978
• MDR Text Key: 204375352
• Report Number: 1319211-2020-00058
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• PMA/PMN Number: K080287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1