MAUDE Adverse Event Report: ATRICURE, INC. ISOLATOR SYNERGY" ENCOMPASS CLAMP AND GUIDE; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES

Model Number	OLH
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Cardiac Perforation (2513)
Date of Event	08/26/2024
Type of Reportable Event	Death
Event or Problem Description
A patient underwent coronary artery bypass graft and aortic root replacement procedure, with concomitant posterior wall encircling ablation using an olh via median sternotomy.When patient was taken off cardiopulmonary bypass bleeding was observed from the left atrium and bypass was reinitiated.A tear was located along the roof of the left atrium and repaired with four pledgeted sutures.The patient was then weaned off bypass and returned to the intensive care unit.Four hours post procedure, the patient was unable to be extubated and exhibited sign of a stroke.A computed tomography scan revealed a left cerebral infarct.Thrombus was removed from the left middle cerebral artery, and it was discovered that there was a 90% stenosis of that vessel.The patient was placed on supportive care and died on the fourth post operative day.While atricure cannot confirm that device caused or contributed to patient's complication or demise, we are reporting per cfr 21 part 803.There was no reported device malfunction, and the adverse event was the result of a procedural complication.
Additional Manufacturer Narrative
The device was not returned for evaluation however, a device history review was conducted and there is nothing in the product history record that would indicate that the devices were released with any non-conformances that would contribute to the subject complaint.

• Brand Name: ISOLATOR SYNERGY" ENCOMPASS CLAMP AND GUIDE
• Common Device Name: ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES
• 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: 20286897
• Report Number: 3011706110-2024-00054
• Device Sequence Number: 7284050
• Product Code: OCL
• UDI-Device Identifier: 10840143905834
• UDI-Public: (01)10840143905834(17)270501(10)141322
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K210477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2024

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 Model Number: OLH
• Device Catalogue Number: A001143
• Device Lot Number: 141322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Death
• Patient Age: 66 YR
• Patient Sex: Male