MAUDE Adverse Event Report: ANGIODYNAMICS NANOKNIFE SYSTEM; LECD THERMAL ABLATION SYSTEM

Model Number 20300101

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

Patient Problem Atrial Fibrillation (1729)

Event Date 01/13/2014

Event Type  Injury  

Event Description

As reported (b)(4) 2014, a (b)(6) old male patient presented for a nanoknife ablation for two lesions of the liver.The first ablation was successfully completed with no reports of complications or device malfunctions.During the second ablation, the patient experienced atrial fibrillation.The procedure was aborted and a cardiologist was consulted.The cardiologist used a defibrillator to regulate the patient's heartbeat.It was determined the patient's second lesion would be treated using a combination of rfa and stereoactive ablation radiation therapy.There was no report of permanent harm or injury to the patient due to the event.It was reported the nanoknife system is available for return for evaluation to the manufacturer.

Manufacturer Narrative

It was reported that the device involved in the incident is available to be returned to the manufacturer for evaluation.To date, the device has yet to be returned.Attempts are being made to obtain the device.An investigation into the root cause for event is currently in progress.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 f/u medwatch.

• Brand Name: NANOKNIFE SYSTEM
• Type of Device: LECD THERMAL ABLATION SYSTEM
• Manufacturer (Section D): ANGIODYNAMICS; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury ave.; queensbury NY 12804
• Manufacturer Contact: dan anderson ; 603 queensbury ave.; queensbury, NY 12804 ; 5187981215
• MDR Report Key: 3645535
• MDR Text Key: 15270552
• Report Number: 1319211-2014-00014
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K080376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/21/2014

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 20300101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2014
• Initial Date FDA Received: 02/13/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR