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

Model Number 001-700-001MI

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

Patient Problem Stroke/CVA (1770)

Event Date 02/28/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation; however, the device history review was unable to be completed as the relevant device lot/serial number was not reported or able to be subsequently ascertained.The complaint could not be confirmed.Adverse event, discarded by facility.

Event Description

A totally thoracoscopic procedure was performed on a patient in his late 60's who had a previous history of pericarditis and had a pleural effusion at time of operation.It was noted that there were a lot of adhesions.Patient had an act of 280, generator was set at 70*c, eight (8) minute ablations done.Day 1 post op, the patient was found to be ataxic and a ct was done that confirmed a cva.Patient was discharged from the hospital and is recovering.

• Brand Name: COBRA FUSION 150 ABLATION MININALLY INVASIVE SYSTEM
• Type of Device: COBRA FUSION 150 ABLATION MININALLY INVASIVE SYSTEM
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: ranjana iyer ; 7555 innovation way; mason, OH 45040 ; 5137555320
• MDR Report Key: 6420676
• MDR Text Key: 70445612
• Report Number: 3011706110-2017-00032
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/08/2017

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: Physician
• Device Model Number: 001-700-001MI
• Device Catalogue Number: 001-700-001MI
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2017
• Initial Date FDA Received: 03/21/2017
• 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; Other