MAUDE Adverse Event Report: ATRICURE, INC. ATRICLIP LAA EXCLUSION SYSTEM; CLIP, IMPLANTABLE

Model Number	PRO245
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of atrial fibrillation.Procedure: convergent maze and left atrial appendage clip.During the procedure, the handle on the device would not release.Another device used without problem.No known harm to patient.Manufacturer response for clip, implantable, atriclip laa exclusion system (per site reporter).Will obtain.

• Brand Name: ATRICLIP LAA EXCLUSION SYSTEM
• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• MDR Report Key: 19905096
• Report Number: 19905096
• Device Sequence Number: 17935550
• Product Code: FZP
• UDI-Device Identifier: 10840143900198
• UDI-Public: (01)10840143900198(17)240701(10)112
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 07/05/2024
• Report Date (Section F): 07/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PRO245
• Device Catalogue Number: A000967
• Device Lot Number: 112370
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Sex: Male
• Date Report Sent to FDA: 07/05/2024