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

Model Number 27200-5P

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

Patient Problem Atrial Fibrillation (1729)

Event Date 05/26/2014

Event Type  Injury  

Event Description

As reported on (b)(6) 2014, a (b)(6) female patient presented for a lecd thermal ablation of the liver.During the ablation, it was noted the patient developed arterial fibrillation.The treating physician determined to continue with the procedure.There was no report of permanent harm or injury to the patient due to the event.The nanoknife system was reported as available for return to the manufacturer for evaluation.

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 incident is currently in progress.The results of the investigation will be sent via a follow up medwatch.A review of the device history records was performed for the serial number (b)(4).A review of the device history records for the sulis accusync (serial number (b)(4)) noted no repairs, servicing and/or upgrades since the unit was manufactured.The review confirms that the unit met all material, assembly, and performance specifications.(b)(4).

• Brand Name: ACCUSYNC
• 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: 3874922
• MDR Text Key: 19586765
• Report Number: 1319211-2014-00083
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/26/2014

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: 27200-5P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2014
• Initial Date FDA Received: 06/11/2014
• 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: 74 YR