MAUDE Adverse Event Report: ATRICURE, INC. COBRA FUSION 150 ABLATION SYSTEM

Model Number 700-001

Device Problem Material Integrity Problem (2978)

Patient Problem Stenosis (2263)

Event Date 12/05/2014

Event Type  Injury  

Event Description

It was reported to the articure area director by the surgeon that immediately following a stand-alone ablation procedure performed via sternotomy, utilizing the cobra fusion 150, an abnormal ekg implied that the coronary artery had become occluded.After the procedure, the patient was sent to the cath lab for conformation of the occlusion and placement of a stent.The surgeon indicated that the he did not feel the event was a result of usage of the cobra fusion device.The patient, a male in his (b)(6) did very well and was released earlier than expected from the hospital.The surgeon also reported that the procedure was performed via sternotomy as a result of concern with the patient's size/obesity.In addition, it was noted that when the surgeon had nearly completed the lesion set and was positioning the device for the final time the end effector magnet on the introducer became detached.

Manufacturer Narrative

(b)(4).There was no report that use of the device attributed to the occlusion of the coronary artery and subsequent placement of a stent.However, analysis of the device was able to confirm that the magnet had pulled free from the introducer.More specifically, the braided tubing to the u-joint bond failed.The complaint with regard to the magnet detachment was confirmed.A device history review was performed and there were no non-conformances or re-works that would have caused or contributed to either of the reported conditions.

• Brand Name: COBRA FUSION 150 ABLATION SYSTEM
• Type of Device: COBRA FUSION 150 ABLATION SYSTEM
• Manufacturer (Section D): ATRICURE, INC.; west chester OH 45069
• Manufacturer Contact: john huff ; 6217 centre park drive; west chester, OH 45069 ; 5136644725
• MDR Report Key: 4410101
• MDR Text Key: 5163704
• Report Number: 3003502395-2015-00005
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2016
• Device Model Number: 700-001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/16/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2013
• 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