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

Model Number 001-700-001

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

Patient Problem Thrombus (2101)

Event Type  Injury  

Manufacturer Narrative

Complaint number: (b)(4).The device was not returned for evaluation, complaint could not be confirmed.Device discarded by facility.

Event Description

At a conference meet regarding hybrid ablation with cobra fusion device slide presentation, it was reported by the surgeon, post surgery, one of his patient experienced tia reasonably suggesting that the device may have caused or contributed to the event.

• Brand Name: COBRA FUSION 150 ABLATION SYSTEM
• Type of Device: COBRA FUSION 150 ABLATION SYSTEM
• Manufacturer (Section D): ATRICURE, INC; 6217 centre park drive; west chester OH 45069 3886
• Manufacturer Contact: ranjana iyer ; 6217 centre park drive; west chester, OH 45069-3886 ; 5137555328
• MDR Report Key: 5573794
• MDR Text Key: 42539390
• Report Number: 3003502395-2016-00012
• 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: other
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 001-700-001
• Device Catalogue Number: 001-700-001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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): Other