MAUDE Adverse Event Report: ATRICURE, INC. ISOLATOR® SYNERGY ENCOMPASS CLAMP; ELECTROSURGICAL DEVICE

Model Number	OLH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	02/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent a coronary artery bypass graft (cabg) procedure with concomitant cardiac ablation using an olh device.While positioning the olh clamp, the physician identified an injury, which was repaired with suture.The primary procedure was completed however, the concomitant procedure was aborted.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.
Additional Manufacturer Narrative
Corrected b4 model number from "encompass synergy clamp (long)' to "olh".

• Brand Name: ISOLATOR® SYNERGY ENCOMPASS CLAMP
• Common Device Name: ELECTROSURGICAL DEVICE
• 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: 21711760
• Report Number: 3011706110-2025-00016
• Device Sequence Number: 10010241
• Product Code: OCL
• UDI-Device Identifier: 10840143905193
• UDI-Public: (01)10840143905193(17)250301(10)118095
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K221358
• 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,Followup
• Report Date (Section B): 05/06/2025

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: 03/01/2025
• Device Model Number: OLH
• Device Catalogue Number: A001143
• Device Lot Number: 118095
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2022
• 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: Unknown