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

Model Number 20300101

Device Problem Insufficient Information (3190)

Patient Problems Atrial Fibrillation (1729); High Blood Pressure/ Hypertension (1908)

Event Date 12/12/2014

Event Type  Injury  

Event Description

As reported on 12 december 2014, a (b)(6) male with a history of atrial fibrillation and atrial flutter presented for a nanoknife procedure of a liver lesion.During the nanoknife procedure, the patient experienced a few episodes of atrial fibrillation and hypertension.The anesthesiologist and crna gave esmolol (60mg total), prop hallo, fentanyl, and increased gas to assist in the return to a normal sinus cardiac rhythm and blood pressure.The crna has no concerns with regards to the condition of the patient post procedurally.The patient is expected to be discharged normally with no additional tests or concerns from this event.During the procedure, the nanoknife generator, disposable probes, and the accusync performed as expected with no issues or errors.

Manufacturer Narrative

This report is not to report a device malfunction, but a patient response to the procedure.Per the information provided, the patient had a history of atrial fibrillation and atrial flutter.The nanoknife generator user manual states that nanoknife system should not be used with patients who have a history of cardiac arrhythmia.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.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: LECD THERMAL ABLATION SYSTEM
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 603 queensbury ave.; queensbury NY
• Manufacturer (Section G): ANGIODYNAMICS, INC.; 603 queensbury ave.; queensbury NY 12804
• Manufacturer Contact: dan anderson ; 603 queensbury ave.; queensbury, NY 12804 ; 5187981215
• MDR Report Key: 4356530
• MDR Text Key: 16887600
• Report Number: 1319211-2014-00243
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2014
• 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
• Patient Age: 63 YR