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

Model Number 700-001

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

Patient Problem Death (1802)

Event Date 11/14/2014

Event Type  Death  

Event Description

It was reported that post-operatively to a procedure for mitral valve repair, tricuspid valve repair, occlusion of laa (atriclip 35mm) and concomitant maze utilizing cobra fusion 150, the pt suffered a stroke and subsequently expired on (b)(6) 2014.In addition to the atricure devices utilized the surgeon reporting using the edwards physio ring for the mvr and the edwards mc3 ring for the tvr.The surgeon also reported repair of right atrium and pulmonary artery.Surgeon also advised the ablation was done after mvr and tvr and there was no observation of endocardial damage but the surgeon stated he was not looking for it.He did not believe the event was related to the device.The autopsy revealed a thrombus in the frontal lobe.

Manufacturer Narrative

(b)(4).The device was discarded at the facility and will not be returned to the manufacturer.The device lot number was unable to be ascertained; therefore, a device history review was unable to be performed.There was no device malfunction reported.

• Brand Name: COBRA FUSINO 150 ABLATION SYSTEM
• Type of Device: COBRA FUSINO 150 ABLATION SYSTEM
• Manufacturer (Section D): ATRICURE, INC; west chester OH 45069
• Manufacturer Contact: john huff ; 6217 centre park drive; west chester, OH 45069 ; 5136444725
• MDR Report Key: 4411468
• MDR Text Key: 5171339
• Report Number: 3003502395-2015-00004
• 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: 11/26/2014

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?: No
• Device Operator: Health Professional
• Device Model Number: 700-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/26/2014
• Initial Date FDA Received: 01/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death
• Patient Age: 63 YR