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) a device history review was unable to be completed.The information available was reported from a medical journel article.Discarded by facility.

Event Description

The historic-af trial is the first prospective, multicentre, single arm study designed to evaluate the outcomes of staged endoscopic and transcatheter ablation in patients with standalone, persistent or long­ standing persistent af.The trial recruited hundred patients with non-paroxysmal af refractory to medical therapy, at different european sites.Study methods include thoracoscopic surgical approach providing left atrial epicardial isolation (box-lesion); and in the case of af recurrency after the blanking period (3 months), transcatheter ablation.Study results included, survival and freedom from macce at 30 days was 94%, 30-day mortality was nil, two peri-operative strokes occurred on the second and third days post procedure, both without permanent sequelae.

• 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 Contact: ranjana iyer ; 7555 innovation way; mason, OH 45040 ; 5137555328
• MDR Report Key: 6376827
• MDR Text Key: 69044748
• Report Number: 3003502395-2017-00028
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K113475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/06/2017

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 Model Number: 011-700-001S
• Device Catalogue Number: 001-700-001S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2017
• Initial Date FDA Received: 03/03/2017
• 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): Life Threatening; Other; Required Intervention