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

Model Number 20300101

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

Patient Problem Cardiac Arrest (1762)

Event Date 06/05/2015

Event Type  Injury  

Event Description

As reported on(b)(6) 2015, a (b)(6), male patient presented for a nanoknife treatment of the liver.During the procedure, the patient experienced a cardiac arrest.The treating physician immediately paused energy delivery and the patient was resuscitated.The patient was placed in icu for monitoring and observation.It was reported the patient's condition improved and he was released from icu.As a precaution, the customer is returning the nanoknife system for an assessment and calibration.

Manufacturer Narrative

The reported nanoknife unit has yet to be returned to the manufacturer for a device evaluation.The firm is attempting to obtain the unit.An investigation into the root cause for product problem is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.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 at the time of manufacture.The review confirmed that the unit met all material, assembly, and performance specification prior to distribution.A review of the reported complaints for the previous 15 months and the risk management documentation for this device notes that the reported event does not present a risk to patients or user in a frequency or manner which has not been anticipated.This is not considered a systemic failure mode.The user manual, which supplied with this device, lists arrhythmia as a potential adverse effect that may be associated with the use of the nanoknife system.Complaint #: (b)(4).

Manufacturer Narrative

The reported nanoknife system was assessed at the customer site by angiodynamics' field service engineer.A photograph provided of the ecg cable noted that this is not the ecg cable supplied with the accusync unit.The reported defective device is not an angiodynamics manufactured or distributed device.The nanoknife system was tested per operational verification procedure with the damaged non-angiodynamics' ecg cable and no defects could be found with the unit.The non-angiodynamics' ecg cable was then replaced with the correct ecg cable and the unit was retested per angiodynamics' operational verification procedure.The unit functioned as intended and no defects could be found.There was no malfunction of the nanoknife system (generator and probe).The unit meets all acceptance criteria.Based on information provided, the customer's reported complaint description is confirmed.The root cause for the complaint description could not be determined as the unit functioned as intended while being tested with both the damaged makeshift ecg cable and the correct replaced ecg cable.The nanoknife generator user manual lists arrhythmia, atrial fibrillation or flutter, bigeminy, bradycardia, heart block or atrioventricular block, paroxysmal supraventricular tachycardia, tachycardia, and/ or ventricular fibrillation, as a potential adverse effects.A review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.

• Brand Name: NANOKNIFE SYSTEM
• Type of Device: LOW ENERGY DIRECT CURRENT ABLATION DEVIC
• Manufacturer (Section D): ANGIODYNAMICS; queensbury NY
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury ave; queensbury NY 12804
• Manufacturer Contact: dan anderson ; 603 queensbury ave; queensbury, NY 12804 ; 5187981215
• MDR Report Key: 4906119
• MDR Text Key: 6835152
• Report Number: 1319211-2015-00306
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K080376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 20300101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 70 YR