MAUDE Adverse Event Report: ATRICURE, INC. ENCOMPASS SYNERGY CLAMP (LONG)

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	11/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023 an 84-year-old male patient underwent an on-pump coronary artery bypass graft (cabg) with concomitant left atrial appendage exclusion (laae) and posterior wall encircling ablation using an olh clamp device.Due to the patient having an abnormality with pulmonary veins, surgeon had a difficult time routing the olh behind the heart.During one routing attempt, the posterior aspect of the patient's heart was perforated.Surgeon aborted the ablation procedure, cross-clamped the aorta, and repaired the injury with suture after which he successfully completed the cabg and laae.There was no reported device malfunction, and the adverse event was the result of a procedural complication.
Additional Manufacturer Narrative
(b)(4)- 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-conformance's that would contribute to the subject complaint.

• Brand Name: ENCOMPASS SYNERGY CLAMP (LONG)
• Common Device Name: ENCOMPASS SYNERGY CLAMP (LONG)
• 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: 18332042
• Report Number: 3011706110-2023-00053
• Device Sequence Number: 17827751
• Product Code: OCL
• UDI-Device Identifier: 50840143904064
• UDI-Public: (01)50840143904064(17)260601(10)130787
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/14/2023

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: 130787
• 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: 11/22/2023
• Initial Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2023
• 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 Age: 84 YR
• Patient Sex: Male