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

Model Number	PRO245
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	04/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent minimally invasive (mis) left atrial appendage exclusion (laae) using pro245.After clip placement and deployment, surgeon made an incision on the distal tip of the left atrial appendage (laa) tip to decompress laa.Pulsatile blood flow was noted and did not stop.Surgeon placed a second clip distal to the first clip, which controlled bleeding.There were no confirmed device malfunctions, and this event was the result of a procedural complication.
Additional Manufacturer Narrative
The pro245 was returned with the clip deployed and locked in articulation.The device was reviewed and was found to be conforming.The complaint could not be confirmed for clip closing failure.

• Brand Name: ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP
• 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: 19206027
• Report Number: 3011706110-2024-00031
• Device Sequence Number: 18169415
• Product Code: PZX
• UDI-Device Identifier: 10840143907418
• UDI-Public: (01)10840143907418(17)261001(10)135026
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K210293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 04/29/2024

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: 10/01/2026
• Device Model Number: PRO245
• Device Catalogue Number: A000967
• Device Lot Number: 135026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2023
• 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: PRO235
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown