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

Model Number 20300101

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tachycardia (2095)

Event Date 04/21/2016

Event Type  Injury  

Manufacturer Narrative

This report is not to report a device malfunction, but an adverse patient event.It was reported that the nanoknife system (sn (b)(4)) involved in the incident will not be returned to the manufacturer for evaluation as it was reported to have functioned as intended.An investigation into the root cause for the event is currently in process.A review of the device history records was performed for the serial number (b)(4).The review confirms that the unit met all material, assembly, and performance specifications.(b)(4).No device malfunction, user retained.

Event Description

As reported (b)(6) 2016, a male patient of unknown age presented for an ire (irreversible electroporation) procedure of the liver porta hepatis (segments 4/5).During treatment, certified registered nurse anesthetists noted that the pt was experiencing supraventricular tachycardia (svt).The svt was detected by the sync device and suspended pulse delivery.Crna administered additional sedative and svt resolved.At this point the treatment was approx.90% complete.Treating physician restarted the procedure when the patient once again experienced supraventricular tachycardia (svt).The nanoknife procedure was once again suspended.The crna administered additional sedative.The treating physician allowed approx.20 mins for the additional sedative to take affect before he decided to abort procedure.As soon as the procedure was aborted, the svt spontaneously resolved.It was reported the patient suffered no permanent harm or injury due to the event.As the nanoknife unit functioned as intended, the unit will not be returned for assessment.

Manufacturer Narrative

This medwatch is not to report a device malfunction, but to report an adverse patient effect.There was no report of a device malfunction during the procedure.As there was no unit malfunction, a service order was not opened for the reported unit, sn (b)(4).The unit was not returned for assessment.The customer's reported event description of the patient experiencing svt during the procedure could not be confirmed based on the nature of this adverse event.Supraventricular tachycardia is a know adverse complication for this procedure.A review of the device history records was performed for the reported serial number (b)(4) 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 to this customer account.This unit has had no previous service orders performed.The nanoknife generator user manual contains the following warning "patients with q-t intervals greater than 550 ms (milliseconds) are at an increased risk for inappropriate energy delivery and arrhythmia.Verification of proper function of a synchronization device before initiating energy delivery is essential in these patients.Asynchronous energy delivery (240 ppm (pulses per minute) or 90 ppm modes) might trigger atrial or ventricular fibrillation, especially in patients with structural heart disease.Ensure that proper interventions (e.G.Defibrillator) and appropriately trained personnel are readily available for dealing with potential cardiac arrhythmias.Using qrs synchronization devices whose output is not compatible with the specifications listed in this manual may result in arrhythmias including ventricular fibrillation.Adequate precautions should be taken for patients with implantable electrical devices.There are potential risks associated with the location of the ablation: near the pericardium (tachycardia), or near the vagus nerve (bradycardia)".In addition, the instructions for use, which is supplied to the user with single electrode probes, lists arrhythmias as a potential adverse effect.The accusync user manual which is supplied to the user with the accusync, states that "the accusync 72 is a 3 or 5 lead ecg (electrocardiograph) monitor which detects the r-wave of the ecg signal and generates a signal for output to an external device for precision ecg synchronization (also called r-wave triggering or gating).It consists of an isolation amplifier that obtains the signal from the patient and processes it for display or recording".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 # (b)(4).

• Brand Name: NANOKNIFE SYSTEM
• Type of Device: LOW ENERGY DIRECT CURRENT ABLATION DEVICE
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: law ryan ; 10 glens falls technical park; glens falls, NY 12801 ; 5187424488
• MDR Report Key: 5662516
• MDR Text Key: 45402664
• Report Number: 1319211-2016-00079
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 20300101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention