MAUDE Adverse Event Report: ATRICURE, INC. SYNERGY ABLATION SYSTEM; SYNERGY¿ ABLATION SYSTEM

Model Number OLL2

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

Patient Problem Cardiac Perforation (2513)

Event Date 09/17/2021

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2021 a patient underwent a mitral valve repair and maze procedure.During the maze portion of the procedure a perforation was found along the right atrium and was repaired with suture closure.The procedure was completed, and the patient was stable post procedure.There was no reported device malfunction and this event was the result of a procedural complication.

Manufacturer Narrative

(b)(4).The oll2 device was returned for investigation.Device was able to ablate tissue and create transmural lesions without problem.Device met specification.

• Brand Name: SYNERGY ABLATION SYSTEM
• Type of Device: SYNERGY¿ ABLATION SYSTEM
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• MDR Report Key: 12627864
• MDR Text Key: 280515190
• Report Number: 3011706110-2021-00044
• Device Sequence Number: 1
• Product Code: OCM
• Combination Product (y/n): N
• PMA/PMN Number: P100046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Model Number: OLL2
• Device Catalogue Number: A000362
• Device Lot Number: 97424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Date Manufacturer Received: 09/17/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention