MAUDE Adverse Event Report: ATRICURE, INC. ATRICLIP FLEX-MINI LAA EXCLUSION SYSTEM; IMPLANTABLE CLIP AND CLIP APPLIER

Model Number	ACHM40
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	01/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The achm40 was received for investigation.The device passed all applicable tests and no production nonconformance could be identified.
Event or Problem Description
A patient underwent a coronary artery bypass graft (cabg) surgery with concomitant left atrial appendage exclusion (laae) using an achm40 clip.Following deployment of clip device, the heart was rotated, revealing that the achm40 clip was not positioned at the base of the appendage.The surgeon decided to remove the clip, but inadvertently tore the distal tip of the left atrial appendage during the clip device removal.Following this, the surgeon successfully applied an achv clip and bleeding was controlled.There was no reported device malfunction, and the adverse event was the result of a procedural complication.
Event or Problem Description
Based on the attached letter from the user, there was no injury to the patient.Initially, it was reported that the surgeon tore the distal tip of the left atrial appendage.However, the surgeon has clarified that this information was incorrect.A piece of fatty tissue was attached to the achm40 clip when it was removed, and the surgeon visually confirmed that there was no tear in the left atrial appendage caused by the removal of the achm40 clip.As a result, this event has been reassessed by atricure, and it does not meet the criteria of reporting per part 803.

• Brand Name: ATRICLIP FLEX-MINI LAA EXCLUSION SYSTEM
• Common Device Name: IMPLANTABLE CLIP AND CLIP APPLIER
• 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: 21267854
• Report Number: 3011706110-2025-00010
• Device Sequence Number: 12874377
• Product Code: PZX
• UDI-Device Identifier: 10840143911781
• UDI-Public: (01)10840143911781(17)250901(10)146423
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K234125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2025
• Device Model Number: ACHM40
• Device Catalogue Number: A001404
• Device Lot Number: 146423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2024
• 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: ACHV.
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown