MAUDE Adverse Event Report: ATRICURE, INC. ATRICLIP FLEX-MINI LAA EXCLUSION SYSTEM; LEFT ATRIAL APPENDAGE CLIP, IMPLANTABLE

Model Number	ACHM50
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	04/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent coronary artery bypass graft (cabg) and aortic valve replacement/repair (avr) via median sternotomy with concomitant tampa 2 surgical ablation lesion set and left atrial appendage exclusion (laae).An incision was made in the left atrial appendage (laa) for access to perform the tampa 2 lesion set, which was completed as planned.An achm50 atriclip device was deployed after the concomitant surgical ablation procedure.Postoperatively, the patient was transferred to the open-heart recovery unit but was subsequently returned to the operating room due to bleeding.Upon evaluation, the surgeon identified a small leak at the laa ostium, near the site of the access incision.The laa was oversewn, and the patient recovered without further reported complications.

• Brand Name: ATRICLIP FLEX-MINI LAA EXCLUSION SYSTEM
• Common Device Name: LEFT ATRIAL APPENDAGE CLIP, IMPLANTABLE
• 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 ; 5136641909
• MDR Report Key: 25172950
• Report Number: 3011706110-2026-00024
• Device Sequence Number: 18689788
• Product Code: PZX
• UDI-Device Identifier: 10840143911804
• UDI-Public: (01)10840143911804(17)280901(10)158595
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K234125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 05/14/2026

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: ACHM50
• Device Catalogue Number: A001406
• Device Lot Number: 158595
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/17/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2025
• 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: Life Threatening; Required Intervention
• Patient Sex: Male