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

Model Number	PRO240
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	04/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022 a patient underwent a robotic cryo maze with concomitant left atrial appendage management.Prior to clip placement, the physician noticed a thrombus in the laa, but proceeded with the procedure.The clip was deployed and during deployment the thrombus migrated into the left atrium and then out of the atrium into the body.Post-procedure, the clot embolized to left kidney and was removed in a follow-up procedure.The patient is doing well and there were no long-term complications.This was a procedural complication with no reported device malfunction.
Additional Manufacturer Narrative
Case (b)(6) the pro240 device was not returned for evaluation, but a device history review was obtained for lot number mf1152a.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.

• 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: 14394557
• Report Number: 3011706110-2022-00017
• Device Sequence Number: 20276097
• Product Code: PZX
• UDI-Device Identifier: 30840143900185
• UDI-Public: 30840143900185
• 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: 2022
• 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): 05/13/2022

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: 11/01/2022
• Device Model Number: PRO240
• Device Catalogue Number: A000966
• Device Lot Number: MF1152A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 05/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2019
• 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: Life Threatening; Required Intervention
• Patient Sex: Unknown