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

Model Number 20300101

Device Problem Pacing Problem (1439)

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

Event Date 05/15/2023

Event Type  malfunction  

Event Description

An issue with a nanoknife 3.0 generator was reported by an end user.It was reported the unit had a pulse delivery delay due to inconsistent patient input ecg " info : consequence : "need to wait between pulses trains".There was no stoppage of the procedure due to device malfunction, the procedure just took a longer to complete the planned treatment (i.E.Greater than 30 minutes).It was confirmed that the patient was stable under ga and no additional intervention required.This event meets the criteria a reportable adverse event; patient safety risk due to prolonged procedure greater than 30 minutes (extended sedation).

Manufacturer Narrative

The nanoknife generator has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Manufacturer Narrative

Returned for evaluation was a nanoknife generator unit.The reported complaint description is not definitively confirmed for the nanoknife generator.The unit was functionally tested and functioned as intended.The reported complaint was caused by the ivy that was used in this event (reference (b)(4)).However, the unit failed the electrical safety test on the protective earth resistance due to no connection on the bnc connector where the ivy should be connected.The bnc connector cable was replaced.The combination of the faulty ivy and the bnc connector cable could have caused the reported complaint.The root cause for the ecg sync was not able to be definitively determined because the unit functioned as intended and met all acceptance criteria when tested alone.Potential contributing factors to the ecg sync issue observed during the procedure is a faulty ivy (reference (b)(4)) and a bad connection between the bnc connector cable and the interface board, which the bnc connector cable was replaced.The root cause for the grounding issue was determined to be caused by a faulty bnc connector cable, which was replaced.The generator was tested with the new bnc connector cable per svc-002-s06 functional test and electrical safety per svc-027 and met all acceptance criteria.A review of the device history records (service order history) was performed for the reported serial number (b)(6) for any deviations related to the reported failure mode of the complaint.The review confirmed that the unit met all material, assembly, and performance specification prior to distribution; i.E.No ncr associated with reported failure mode.Labeling review: (ecg sync) the user manual, 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 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.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
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 17125202
• MDR Text Key: 317342716
• Report Number: 1319211-2023-00041
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K102329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/22/2023

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 Model Number: 20300101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2023
• Initial Date FDA Received: 06/14/2023
• Supplement Dates Manufacturer Received: 08/21/2023
• Supplement Dates FDA Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male