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

Model Number 700-001S

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

Patient Problem Thromboembolism (2654)

Event Date 11/16/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned to atricure for evaluation as there was no indication of a device defect or malfunction.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.Discarded by facility.

Event Description

Patient had a stand-alone procedure that was off-pump.The 10,000 units of heparin were given prior to initiating fusion on the right side (act 313) 8-minute application.The 5,000 units given prior to initiating fusion on the left side (act 338) 8-minute application for a combined application of 16 minutes.Temp was 65.Patient experienced a central ocular embolism, still has peripheral vision.Carotid arteries were clear; it is believed it was a cardio embolic event.

• Brand Name: COBRA FUSION 150 ABLATION SYSTEM
• Type of Device: COBRA FUSION 150 SURGICAL SYSTEM
• Manufacturer (Section D): ATRICURE INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: ranjana iyer ; 7555 innovation way; mason, OH 45040 ; 5137555328
• MDR Report Key: 6166483
• MDR Text Key: 62130218
• Report Number: 3003502395-2016-00168
• 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: 11/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 700-001S
• Device Catalogue Number: 700-001S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• 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): Disability
• Patient Age: 69 YR
• Patient Weight: 80