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

Model Number 001-700-001S

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

Patient Problems Stroke/CVA (1770); Blurred Vision (2137)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The devices were not returned for evaluation as the adverse event occurred post-procedure.A product history review was unable to be performed; no device specific lot or serial numbers were reported.There was no reported device malfunction during the initial procedure.

Event Description

On (b)(6) 2017, a male patient received an off-pump, totally thoracoscopic maze procedure with laa management using a cobra fusion 150 ablation system.The patient was heparinized for the procedure with an act measured at over 300 seconds.The heparin was not reversed post procedure, and oral anticoagulants were used prior to and post procedure.The procedure reportedly went as expected with between 15 and 20 ablations performed on the pulmonary veins.Within one or two days post procedure the patient reportedly had a stroke with the residual effects of lateral blurry vision.The current patient status is fine.There was no reported device malfunction with the initial procedure.

• Brand Name: COBRA FUSION 150 ABLATION SYSTEM
• Type of Device: COBRA FUSION 150 ABLATION SYSTEM
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer (Section G): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: anupam bedi
• MDR Report Key: 7138424
• MDR Text Key: 95526815
• Report Number: 3011706110-2017-00109
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Model Number: 001-700-001S
• Device Catalogue Number: 001-700-001S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2017
• 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
• Treatment: MID1, EMR2, EML2, MLP1, PRO2
• Patient Outcome(s): Life Threatening; Disability