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 Perforation (2001)

Event Date 07/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The oll2 device was not returned for evaluation but a device history review was obtained for lot number 86829.There is nothing in the device history record that would indicate that the devices were released with any non-conformances that would contribute to the complaint.

Event Description

It was reported that on (b)(6) 2019 an (b)(6) year old patient underwent an on-pump mitral valve procedure, tricuspid repair, and pulmonary vein isolation.The surgeon noted that there was a good amount of fat on the pulmonary vein (pv).The surgeon was using an oll2 for the ablation and after the first ablation, there seemed to be a tear on the front side of the left inferior pv.After the second ablation of the same line, a little bleeding occurred from the torn tissue.During the third ablation near the left atrium, the surgeon noted bleeding and at this point, used a pledgetted suture to stop bleeding from epicardial side.When the mitral valve repair was completed, he also sutured bleeding site from the endocardial side.The surgeon does not attribute the bleeding to the oll2 device but to vulnerable vein tissue relating to the patient undergoing hemodialysis.Post-procedure patient remained stable.This is was a procedure related 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 ; 5137554563
• MDR Report Key: 8883706
• MDR Text Key: 153994843
• Report Number: 3011706110-2019-00038
• Device Sequence Number: 1
• Product Code: OCM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2021
• Device Model Number: OLL2
• Device Catalogue Number: A000362-JP
• Device Lot Number: 86829
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/10/2018
• 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; Required Intervention
• Patient Age: 83 YR