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

Model Number OLL2

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

Patient Problem Pulmonary Valve Stenosis (2024)

Event Date 12/24/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The oll2 device was not returned for evaluation and a device history record review was unable to be completed as the relevant lot number for the device was not reported or able to be subsequently ascertained.

Event Description

It was reported that in (b)(6) 2020 a patient with a history of aortic stenosis and paroxysmal atrial fibrillation underwent an aortic valve replacement and pulmonary vein isolation that utilized an oll2 device.In (b)(6) 2020, the patient described symptom of shortness of breath.In (b)(6) 2020, the symptom had gotten worse and a computed tomography scan was performed where patient was diagnosed with pulmonary vein stenosis.Surgical intervention was performed on (b)(6) 2020 to restore pulmonary vein function.This was a procedural complication.There was no reported device malfunction.

• Brand Name: ATRICURE SYNERGY ABLATION SYSTEM
• Type of Device: ATRICURE SYNERGY 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: john ehlert ; 7555 innovation way; mason, OH 45040 ; 5136448220
• MDR Report Key: 11178864
• MDR Text Key: 227128119
• Report Number: 3011706110-2021-00002
• Device Sequence Number: 1
• Product Code: OCM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P1000046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OLL2
• Device Catalogue Number: A000362-JP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2020
• Was Device Evaluated by Manufacturer?: No
• 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: ASU/ASB
• Patient Outcome(s): Life Threatening