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

Model Number 20300101

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that the nanoknife system (sn 02660915) involved in the incident is available to be returned to the manufacturer for evaluation.To date, the generator has yet to be returned.The results of the unit evaluation will be sent via a follow up medwatch.Complaint (b)(4).

Event Description

A patient of unknown age and gender presented for an ire procedure for an ablation of oral cancer meta in central liver using the nanoknife system.During the procedure, it was reported the ivy sync device, used with the nanoknife system, was being disturbed by the nanoknife pulses.Due to this disturbance, it was reported the procedure was prolonged for greater than an hour.The procedure was successfully completed with no adverse patient effect due to this event.This event meets the criteria of an adverse event due to patient safety risk, as the patient was sedated longer than expected.As a precaution the customer has requested the unit be assessed.

Manufacturer Narrative

As the reported nanoknife unit was not returned, angiodynamics is unable to perform an evaluation.The reported complaint description is not confirmed because the unit was not returned for evaluation.The root cause for the ecg sync issue was not determined because the unit was not returned for evaluation.This is the first reported error of this unit for ecg sync issue.A review of the device history records (service order system) was performed for the reported serial number (b)(6) 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 (nanoknife user manual, 160-105261-21r02 version 2.2.1), which is supplied to the user with this unit states "ecg synchronized status indicator is for pulse timing status listed below: "ecg disabled" if 90 ppm or 240 ppm are selected."ecg synchronized" if ecg synchronization is selected and the signal is synchronized."ecg noisy" if ecg synchronization is selected and signal is too fast."ecg no signal" if ecg synchronization is selected and signal is too slow or not present." and "if ecg synchronization was selected, and the ecg signal is noisy, low, or not present during the procedure, the system will indicate by displaying the "pulse timing" status.Energy delivery will not be allowed to continue until the signal is synchronized or the procedure can be restarted if the user returns to one of the screens that has an active settings button to access the pulse timing control screen, and selects either 90 ppm or 240 ppm.This is explained further in section 5.1.3, information screen: clinical data." and "ecg synchronized when first entering the pulse generation screen (figure 6.3.1), the system requires 3.5 seconds to verify the status of the ecg signal.After the 3.5 seconds and before delivering a test pulse, if the ecg signal is synchronized, the button for deliver test pulse will be active and the run section of the screen will display: click 'deliver test pulse' to start." and "after the 3.5 seconds and before delivering a test pulse, if the ecg signal is slow or not present, the button deliver test pulse will be inactive and the run section of the screen (figure 6.3.2) will display: "external ecg trigger no signal.Please check the connection."" and "troubleshooting for "ecg no signal": verify that ecg cables are firmly connected to buttons.Check the display of the synchronization device[?]is it generating a synchronization signal on each r-wave? toggle different lead combinations on the synchronization device until a satisfactory synchronization signal is found.Relocate ecg buttons on patient and try lead combinations again.Check the cable between the synchronization device and generator.Verify that the patient heart rate is not 17 bpm or less 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).

• Brand Name: NANOKNIFE SYSTEM
• Type of Device: LOW ENERGY DIRECT CURRENT ABLATION SYSTEM,
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury, ny
• MDR Report Key: 9921964
• MDR Text Key: 188560070
• Report Number: 1319211-2020-00026
• Device Sequence Number: 1
• Product Code: OAB
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20300101
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1