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

Model Number COBRA FUSION 150 ABLATION SYSTEM

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

Patient Problem Stroke/CVA (1770)

Event Date 05/25/2017

Event Type  Injury  

Manufacturer Narrative

Case-(b)(4).The device was not returned for evaluation; however, the device history review was completed.There is nothing in the device history review to indicate the devices were released with any non-conformances that would have contributed to the complaint.

Event Description

An off-pump, totally thoroscopic maze procedure was performed with the procedure consisting of bi-lateral pvi with roof and floor lesion treatment plus occlusion of the laa for treatment of long standing paroxysmal atrial fibrillation.The patient was heparinized with greater than 10k of heparin and had an act of greater than 300 that was not reversed post procedure.Both a emr2 and a eml2 gp¿s were tested and a fusion 150 was used on the right and left side.Hand pieces were cleaned between ablations.The procedure continued where a pro235 was applied without incident to the left atrial appendage.The patient left the room in nsr and sometime during the following day suffered a significant right brain stroke and has limited left sided function.Patient is still in the hospital and plans are being made to move her to a rehab facility.

• 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: 6661940
• MDR Text Key: 78228177
• Report Number: 3011706110-2017-00057
• 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: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 03/01/2020
• Device Model Number: COBRA FUSION 150 ABLATION SYSTEM
• Device Catalogue Number: 001-700-001S
• Device Lot Number: M10188
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/26/2017
• 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; Required Intervention; Disability
• Patient Age: 60 YR