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

Model Number 011-700-001S

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

Patient Problem Stroke/CVA (1770)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was discarded post procedure by facility.The device history review was unable to be completed as the relevant device lot number was not reported or able to be subsequently ascertained.The complaint could not be confirmed.

Event Description

It was reported and confirmed on 17 mar 2017 that in approximately (b)(6) 2015 there was a stand-alone fusion ablation through right thoracotomy using the cobra fusion 150 system.Patient was obese, off-pump procedure and was given 5000 units of heparin.Two to three days post procedure, the patient suffered a stroke.The current status of the patient, there was continuing serious aphasia issues within the last year but that is the most recent status.Surgeon does not know if the fusion device may have caused or contributed to the stroke event.

• Brand Name: COBRA FUSION 150 ABLATION SYSTEM
• Type of Device: COBRA FUSION 150 ABLATION SYSTEM
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; cincinnati OH 45040 0000
• Manufacturer Contact: ranjana iyer ; 7555 innovation way; cincinnati, OH 45040-0000 ; 5137555328
• MDR Report Key: 6464456
• MDR Text Key: 71890024
• Report Number: 3011706110-2017-00034
• 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: Other
• Type of Report: Initial
• Report Date: 01/30/2017

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: Other
• Device Model Number: 011-700-001S
• Device Catalogue Number: 011-700-001S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/06/2017
• 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): Hospitalization; Life Threatening; Other; Disability