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

Model Number 20300101

Device Problem Insufficient Information (3190)

Patient Problem Arrhythmia (1721)

Event Date 07/22/2014

Event Type  Injury  

Event Description

As reported on (b)(6) 2014, a (b)(6) patient presented for a lecd thermal ablation of the liver.During the ablation, the accusync unit indicated the patient was experiencing arrhythmia.The unit paused delivery of pulses until the heart rate returned to normal.Esmolol was used to manage the arrhythmia during the ablation and prophylactically for subsequent ablations.The procedure was successfully completed without further complications.It was reported the patient suffered no harm or injury due to the event.It was reported the accusync unit would not be returned for assesment and repair by the customer.

Manufacturer Narrative

This report is not to report a device malfunction, but a patient response to the procedure.The nanoknife system was not returned to angiodynamics for evaluation and repair.The unit had functioned as intended.The clinical specialist present at the time of the event provided event information and follow up information of the patient.The customer's reported complaint description is confirmed.Although the reported complaint description is confirmed, a definitive root cause cannot be determine.However, arrhythmia is a known procedural complication and listed in the nanoknife user manual, provided with this unit to the customer.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.The serial number for the accusync unit was not provided by the user.A review of the reporting customer's inventory for accusync noted only one active unit; accusync (7200-5p) serial number (b)(4).A review of the device history records was performed for the accusync serial (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.(b)(4).

• Brand Name: NANOKNIFE SYSTEM
• Type of Device: LECD THERMAL ABLATION SYSTEM
• 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: 4009368
• MDR Text Key: 4687998
• Report Number: 1319211-2014-00105
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2014
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2014
• 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: 69 YR