MAUDE Adverse Event Report: ATRICURE, INC. ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP

Model Number	PRO240
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	08/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) - the device was not returned for investigation and no device malfunction was alleged.The product history record was reviewed for lot 119591.There is nothing in the device history record that would indicate that the devices were released with any non-conformances that would contribute to the complaint.
Event or Problem Description
On (b)(6) 2023 a 73-year-old male patient underwent a hybrid (convergent approach) ablation procedure with concomitant left atrial appendage exclusion.The ablation procedure was completed successfully.While manipulating the left atrial appendage with an endoscopic kittner and positioning the pro240 atriclip device, bleeding was observed.The procedure was converted to median sternotomy approach and the injury, located at the base of the pulmonary artery and right ventricular outflow tract, was repaired successfully.Post-operatively, the patient developed sepsis and expired.It is unknown if an autopsy will be conducted to determine cause of death.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

• Brand Name: ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP
• Common Device Name: ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP
• 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: 17749825
• Report Number: 3011706110-2023-00029
• Device Sequence Number: 14866443
• Product Code: PZX
• UDI-Device Identifier: 30840143900185
• UDI-Public: (01)30840143900185(17)250401(10)119591
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K210293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 09/14/2023

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: 04/01/2025
• Device Model Number: PRO240
• Device Catalogue Number: A000966
• Device Lot Number: 119591
• 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: 08/15/2023
• Initial Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Death
• Patient Age: 73 YR
• Patient Sex: Male