MAUDE Adverse Event Report: ATRICURE, INC. ATRICLIP® PRO-V® LAA EXCLUSION SYSTEM; IMPLANTABLE CLIP AND CLIP APPLIER

Model Number	PROV45
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	01/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent a totally thoracoscopic surgical ablation procedure with concomitant left atrial appendage exclusion (laae) using a prov45 device.The clip device was placed on the left atrial appendage (laa) and placement was visually confirmed to be fully across the base of laa.After the clip was deployed, the surgeon opened tip of appendage, and bleeding occurred.A second clip was placed distal to the original clip, which successfully controlled the bleeding.There was no reported device malfunction, and the adverse event was the result of a procedural complication.
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.

• Brand Name: ATRICLIP® PRO-V® 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: 21265596
• Report Number: 3011706110-2025-00008
• Device Sequence Number: 4538574
• Product Code: PZX
• UDI-Device Identifier: 10840143912122
• UDI-Public: (01)10840143912122(17)270801(144502)
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K233407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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
• Report Date (Section B): 01/29/2025

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 Model Number: PROV45
• Device Catalogue Number: A000973-4
• Device Lot Number: 144502
• 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: 01/07/2025
• Initial Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown