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 09/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation but a device history review was obtained for lot number 69151.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 on (b)(6) 2018 of an event from procedure on (b)(6) 2017, that a (b)(6) -year-old female patient underwent a maze procedure where an atricure oll2 was used.The surgeon ablated the right pulmonary vein and once completed, bleeding was observed from ablation line.The source of the bleeding was closed via suture.Post-op, the patient developed anemia and pleural effusion which was drained.Currently, the heart rate is back to normal sinus rhythm and the patient is doing fine.No device malfunction was reported.

• 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: anupam bedi ; 7555 innovation way; mason, OH 45040
• MDR Report Key: 7581730
• MDR Text Key: 110455025
• Report Number: 3011706110-2018-00170
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Expiration Date: 10/01/2019
• Device Model Number: OLL2
• Device Catalogue Number: A000362-JP
• Device Lot Number: 69151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/11/2016
• 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: 75 YR