MAUDE Adverse Event Report: ATRICURE, INC. EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX; SURGICAL CARDIAC ABLATION DEVICE, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number	CDK-1413
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	06/23/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
A patient underwent a hybrid convergent epicardial and endocardial ablation procedure via a sub-xyphoid approach using a cdk-1413 device.Post-procedure electrocardiogram (ecg) indicated the patient was in sinus rhythm, and they were discharged on post-operative day 3.However, on post-operative day 4, a tte revealed a moderate to large pericardial effusion.The patient was readmitted on post-operative day 8 and treated with steroids.They were discharged home on post-operative day 13 but returned on post-operative day 19, complaining of shortness of breath, and were subsequently admitted for a pericardial window.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

• Brand Name: EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX
• Common Device Name: SURGICAL CARDIAC ABLATION DEVICE, FOR TREATMENT OF ATRIAL FIBRILLATION
• 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: 19838800
• Report Number: 3011706110-2024-00046
• Device Sequence Number: 12482456
• Product Code: OCM
• UDI-Device Identifier: 10840143904554
• UDI-Public: (01)10840143904554(17)260101(10)126378
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P200002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/26/2024

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 Expiration Date: 01/01/2026
• Device Model Number: CDK-1413
• Device Catalogue Number: CDK-1413-3
• Device Lot Number: 126378
• 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: 07/09/2024
• Initial Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CSK-6131, ARCTIC FRONT ADVANCE, TACTICATH
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male