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

Model Number OLH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Perforation (2513)

Event Date 08/14/2023

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 323549540
• Report Number: 3011706110-2023-00030
• Device Sequence Number: 1
• Product Code: OCL
• UDI-Device Identifier: 30840143904800
• UDI-Public: (01)30840143904800(17)260601(10)130635
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210477
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/20/2023
• 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 Sex: Female