MAUDE Adverse Event Report: ATRICURE, INC. ISOLATOR SURGICAL ABLATION SYSTEM; SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE, INCLUDING

Model Number	EML2
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Vascular Dissection (3160)
Date of Event	01/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Atricure rf (radiofrequency) clamp was placed on left pulmonary vein.When removing clamp, there was dark red blood.Clamp was immediately placed back on for control of hemorrhage.Patient was emergently cannulated and placed on cardiopulmonary bypass for repair of pulmonary vein.Site of bleeding was repaired with incorporeal stitches.

• Brand Name: ISOLATOR SURGICAL ABLATION SYSTEM
• Common Device Name: SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE, INCLUDING
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• MDR Report Key: 21147638
• Report Number: 21147638
• Device Sequence Number: 9134986
• Product Code: OCL
• UDI-Device Identifier: 30840143902387
• UDI-Public: (01)30840143902387
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/10/2025
• Report Date (Section F): 01/10/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: EML2
• Device Catalogue Number: A000467
• Device Lot Number: 143246C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/14/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Date Report Sent to FDA: 01/10/2025