MAUDE Adverse Event Report: ATRICURE, INC. ISOLATOR® SYNERGY¿ ENCOMPASS CLAMP; SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE, INCLUDING

Model Number	OSH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/15/2025
Type of Reportable Event	Death
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
On (b)(6) 2025 a 76-year-old male patient with a history of afib and mitral regurgitation underwent an mvr via median sternotomy with posterior wall encircling ablation.Previously unrecognized amyloid scarring was present along the dome of the atrium.During the radiofrequency (rf) ablation, an atrial injury occurred.The injury proved irreparable, and the patient expired.

• Brand Name: ISOLATOR® SYNERGY¿ ENCOMPASS CLAMP
• 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
• Manufacturer (Section G): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: patricia craft ; 7555 innovation way; mason, OH 45040 ; 5136441909
• MDR Report Key: 24003548
• Report Number: 3011706110-2026-00048
• Device Sequence Number: 10398380
• Product Code: OCL
• UDI-Device Identifier: 10840143905995
• UDI-Public: (01)10840143905995(17)281001(10)159930
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 01/08/2026

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 Model Number: OSH
• Device Catalogue Number: A001144
• Device Lot Number: 159930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/18/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2025
• 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: Death
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 71 KG