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

Model Number 700-001

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

Patient Problem Stroke/CVA (1770)

Event Date 02/14/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, the surgeon reported to the sales rep that there were two patients who experienced strokes after being treated with the fusion 150 and an unspecified atriclip product.Originally, the ep, suggested that the strokes are originating from manipulation of the laa during clip placement.However, after several conversations with the surgeon who performed the procedures, he believes that the strokes were a result of surgical compilations with the use of the fusion 150 device.The first case, occurred (b)(6) 2013, and was reported on medwatch 3003502395-2015-00020.The second event occurred (b)(6) 2015.During heart ablation using the fusion 150 product, the patient experienced a stroke.Supportive care was provided.As a result of the stroke the patient has permanent left-side paresis and can't speak.

Manufacturer Narrative

(b)(4).The device was not returned to atricure for evaluation and disposed of by the hospital.The lot number of the device was unable to be ascertained.

• Brand Name: COBRA FUSION 150 ABLATION SYSTEM
• Type of Device: COBRA FUSION 150 ABLATION SYSTEM
• Manufacturer (Section D): ATRICURE, INC.; west chester OH
• Manufacturer Contact: john huff ; 6217 centre park drive; west chester, OH 45069 ; 5136444725
• MDR Report Key: 4927683
• MDR Text Key: 22057610
• Report Number: 3003502395-2015-00021
• 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: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 05/05/2015
• 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): Life Threatening