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

Model Number	OLL2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	10/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Case (b)(4): the oll2 was returned and evaluated.The device met all specifications and operated as designed.A device history review was also conducted and there is nothing that would indicate that the devices were released with any non-conformances that would contribute to the reported event.
Event or Problem Description
It was reported on 21-oct-2019 that a (b)(6) female patient with a history of active atrial fibrillation and mitral regurgitation, underwent a mitral valve repair/replacement, tricuspid valve repair, pulmonary vein isolation and left atrial appendage management.Prior to the procedure, a transesophageal echocardiogram was performed, there was no evidence of clots within the left atrial appendage and left atrium.Surgeon used the oll2 for the pulmonary vein isolation.Upon removing the clamp, the surgeon noted that the left pulmonary vein had a small hole in it.The surgeon then sutured the hole and bleeding stopped.Surgeon also verified that the hole was not located in an area where the surgeon was using the oll2 for ablations, but on the left pulmonary vein.The surgery was completed with no patient consequences.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

• Brand Name: ATRICURE SYNERGY ABLATION SYSTEM
• Common Device Name: ATRICURE SYNERGY ABLATION SYSTEM
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• MDR Report Key: 9343705
• Report Number: 3011706110-2019-00055
• Device Sequence Number: 2184282
• Product Code: OCM
• UDI-Device Identifier: 00818354010503
• UDI-Public: (01)00818354010503(17)220601(10)95175
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P100046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2022
• Device Model Number: OLL2
• Device Catalogue Number: A000362
• Device Lot Number: 95175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 11/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 75