MAUDE Adverse Event Report: ATRICURE, INC. ATRICURE DISSECTOR

Model Number	MID1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	02/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Case(b)(4).The device was not returned for evaluation.The device lot number was provided at a later date and the device history record review is pending.
Event or Problem Description
A patient underwent a thoracoscopic left atrial appendage exclusion and left pulmonary vein isolation, during which a mid1 dissector was used.Prior surgical history included an aortic aneurysm repaired with stent.Poor visibility was noted with single-lung ventilation.Surgeon attempted to dissect between the left superior pulmonary vein (lspv) and the left pulmonary artery using the mid1, but bleeding occurred.Site of bleeding site could not be identified, so a small incision was made in the left fourth intercostal space and cardiopulmonary bypass was initiated.The patient became hemodynamically unstable but was stabilized.Bleeding from the inferior vena cava (ivc) was identified and repaired with one pledgeted suture.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

• Brand Name: ATRICURE 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 way; mason, OH 45040 ; 5136448220
• MDR Report Key: 18871020
• Report Number: 3011706110-2024-00021
• Device Sequence Number: 2970749
• Product Code: GDI
• UDI-Device Identifier: 10840143902017
• UDI-Public: (01)10840143902017
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/08/2024

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: 08/01/2026
• Device Model Number: MID1
• Device Catalogue Number: A000195
• Device Lot Number: 133099
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 03/08/2024
• Date Device Manufactured: 09/19/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown