MAUDE Adverse Event Report: ATRICURE, INC. COBRA FUSION 150 ABLATION MINIMALLY INVASIVE SYSTEM; 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 03/07/2017

Event Type  Injury  

Manufacturer Narrative

(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.Adverse event - product was discarded.

Event Description

A female patient, (b)(6) with history of pericarditis.On (b)(6) 2017 patient att procedure, deep style bilateral ablation with laa management.Patient was an obese and had a lot of adhesions once the surgeon got into the pericardium.Patient also had pericardial effusion.The patient was given 10, 000 units of heparin, act of 300, 8 min of ablation.Procedure went well.Post-operative the patient had a stroke with a right hemiplegia.Ct of brain showed large brain infarct.

• Brand Name: COBRA FUSION 150 ABLATION MINIMALLY 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: 6420550
• MDR Text Key: 70435219
• Report Number: 3011706110-2017-00031
• 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 Expiration Date: 01/01/2020
• Device Model Number: 001-700-001MI
• Device Catalogue Number: 001-700-001MI
• Device Lot Number: 71079
• 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
• Date Device Manufactured: 01/25/2017
• 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
• Treatment: 001-700-003; EML2; MAX5; MLP1; PRO240
• Patient Outcome(s): Life Threatening; Other; Required Intervention
• Patient Age: 63 YR