MAUDE Adverse Event Report: ATRICURE, INC. ISOLATOR® SYNERGY¿ ENCOMPASS CLAMP AND GUIDE

Model Number	OLH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	08/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, a female patient underwent aortic valve replacement surgery with concomitant posterior wall encircling ablation using atricure olh clamp.While positioning the clamp, blood was observed, and a tear was identified at the base of the left atrial appendage.Due to appendage morphology as well as injury location and minimal extent of bleeding, the surgeon was able to non-emergently cross-clamp the aorta, after which he elected to excise and over sew the left atrial appendage.The procedure was completed successfully, and the patient was reportedly doing well in their recovery.There was no reported device malfunction.The adverse event was the result of a procedural complication.
Additional Manufacturer Narrative
(b)(4) - the product history record was reviewed for lot 130635.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.

• Brand Name: ISOLATOR® SYNERGY¿ ENCOMPASS CLAMP AND GUIDE
• Common Device Name: ISOLATOR® SYNERGY¿ ENCOMPASS CLAMP AND GUIDE
• 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 45140 ; 5136448220
• MDR Report Key: 17760324
• Report Number: 3011706110-2023-00030
• Device Sequence Number: 17915886
• Product Code: OCL
• UDI-Device Identifier: 30840143904800
• UDI-Public: (01)30840143904800(17)260601(10)130635
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 09/15/2023

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: 06/01/2026
• Device Model Number: OLH
• Device Catalogue Number: A001143
• Device Lot Number: 130635
• 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: 08/18/2023
• Initial Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2023
• 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: Life Threatening; Required Intervention
• Patient Sex: Female