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

Model Number 20300101

Device Problem Failure to Auto Stop (2938)

Patient Problem Atrial Tachycardia (1731)

Event Date 07/14/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported july 15, 2016, a patient of unknown age and gender presented for an ire (irreversible electroporation) procedure of the liver.During the procedure, the nanoknife system displayed a communication error however, continued to deliver pulses.The unit was immediately turned off by the treating physician.The unit was rebooted and the treating physician determined to resume the procedure.During the remaining procedure, the patient experienced ventricular tachycardia/ventricular fibrillation for about one minute.Defibrillation was successfully performed on the patient and again, the physician resumed the procedure.It was reported the patient remained stable for the remainder of the procedure.It was reported the nanoknife system is available for return to the manufacturer for evaluation.

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.The unit was not returned for assessment.The customer's reported complaint description of a patient experiencing ventricular fibrillation during nanoknife ablations was confirmed based on information provided by the treating physician.The treating physician used the defibrillator to regulate the heartbeat.Once the patient returned to normal sinus rhythm, the case was completed without further complications.The patient suffered no lasting, permanent harm.Although the complaint is confirmed, a root cause cannot be determined without receiving the unit to evaluate.It was noted that the mass being treated was extremely close to the heart, increasing the risk for arrhythmia.Ventricular fibrillation is a known adverse complication of 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.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 (see section 5.1.3).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: 5866390
• MDR Text Key: 51812244
• Report Number: 1319211-2016-00112
• 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: Other Health Care Professional
• 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: 08/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 20300101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/15/2016
• 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