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

Model Number	20300101
Medical Device Problem Code	Insufficient Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/26/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the ire generator (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.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.The results of the unit evaluation will be sent via a follow up medwatch.(b)(4).
Event or Problem Description
As reported may 31, 2016, a (b)(6), male patient presented for an ire (irreversible electroporation) procedure of the liver.During the procedure, the accusync displayed a saturation signal.This is a signal the patient experienced an episode of ventricular extrasystoles the 3 cables were replaced and the procedure was successfully completed.It was reported that the patient suffered no adverse effects due to the event.It was reported the nanoknife system is available for return to the manufacturer for evaluation.

• Brand Name: NANOKNIFE SYSTEM
• Common Device Name: LOW ENERGY DIRECT CURRENT ABLATION DEVICE
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 5706119
• Report Number: 1319211-2016-00093
• Device Sequence Number: 113145
• Product Code: OAB
• Combination Product (Y/N): N
• PMA/510(K) Number: K102329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Type of Report: Initial
• Report Date (Section B): 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Model Number: 20300101
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2016
• Initial Report FDA Received Date: 06/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR