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

Model Number OLL2

Device Problem Use of Device Problem (1670)

Patient Problem Perforation (2001)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported by the surgeon that during one of his surgical procedures while ablating the junction where pulmonary vein meets the roof and/or the floor lesions when some bleeding was observed bleeding that may be been attributed to over burning from the oll2 device.Surgeon is theorizing that the point where lesions overlap the tissue may have ¿broken down¿ and bled.Surgeon used a pledgetted suture to close the defect and the patient did well.This event is 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: 8447957
• MDR Text Key: 139695580
• Report Number: 3011706110-2019-00014
• Device Sequence Number: 1
• Product Code: OCM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2019
• 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
• Patient Outcome(s): Life Threatening; Required Intervention