MAUDE Adverse Event Report: ATRICURE, INC. LARIAT RS SUTURE DELIVERY DEVICE

Model Number	30-06
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	09/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) - the lariat device was returned for investigation.The device was visually and functionally tested.The device did not exhibit any anomaly that was deemed as related to the reported event.
Event or Problem Description
On (b)(6) 2022 a patient underwent a lariat procedure.Patient sustained a perforation at the base of the left atrial appendage causing a pericardial effusion that required conversion to sternotomy to repair.This is a procedural complication and there was no confirmed device malfunction related to this complication.

• Brand Name: LARIAT RS SUTURE DELIVERY DEVICE
• Common Device Name: LARIAT RS SUTURE DELIVERY DEVICE
• 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: 15549931
• Report Number: 3011706110-2022-00036
• Device Sequence Number: 2780578
• Product Code: HCF
• UDI-Device Identifier: 30840143903742
• UDI-Public: (01)30840143903742(17)230601(10)P1323V
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K153096
• 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): 10/06/2022

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: 06/01/2023
• Device Model Number: 30-06
• Device Catalogue Number: FG-0028-02
• Device Lot Number: P1323V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2021
• 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: Male