MAUDE Adverse Event Report: ATRICURE, INC. WOLF LUMITIP DISSECTOR

Model Number	WOLF LUMITIP DISSECTOR
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	06/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4), the device was not returned for evaluation, but a device history review is being obtained.If any pertinent information is obtained, a supplemental report will be submitted.
Event or Problem Description
A patient underwent bilateral tt maze procedure using a mid1 dissector.Near the completion of procedure, an injury to the dome of the left atrium occurred.The surgeon decided to convert access to a sternotomy to repair the injury.The injury was repaired and the procedure was completed.This was a procedural complication, and there was no reported device malfunction.

• Brand Name: WOLF LUMITIP DISSECTOR
• Common Device Name: DISSECTOR
• 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 dr; mason, OH 45040 ; 5136448220
• MDR Report Key: 19641005
• Report Number: 3011706110-2024-00043
• Device Sequence Number: 15605955
• Product Code: GDI
• UDI-Device Identifier: 00818354010367
• UDI-Public: 00818354010367
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K111020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/30/2024

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 Model Number: WOLF LUMITIP DISSECTOR
• Device Catalogue Number: A000195
• Device Lot Number: 140513
• 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: 06/24/2024
• Initial Report FDA Received Date: 06/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2024
• 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