MAUDE Adverse Event Report: ATRICURE, INC. ATRICURE BIPOLAR SYSTEM

Model Number EML2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Perforation (2513)

Event Date 02/05/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4) the eml2 device was not returned for evaluation and a device history review was unable to be completed as the relevant lot number for the eml2 device was not reported or able to be subsequently ascertained.

Event Description

It was reported that on (b)(6) 2021 an (b)(6) year-old male patient underwent a bilateral total thorcoscopic (tt) maze procedure.The physician dissected the left pulmonary veins (lpv) with a mid1 and inserted the eml2 clamp.Upon first ablation on the lpv¿s, blood was noticed by the physician.The physician converted the procedure to a median sternotomy where it was found that the patient had a small anomalous appendage originating from the left atrial appendage where the bleeding was originating from.The appendage was closed using a ach35 clip placement which controlled the bleeding and the maze procedure was completed with the patient in normal sinus rhythm and stable post procedure.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

• Brand Name: ATRICURE BIPOLAR SYSTEM
• Type of Device: ATRICURE BIPOLAR SYSTEM
• 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: 11396978
• MDR Text Key: 243735961
• Report Number: 3011706110-2021-00010
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EML2
• Device Catalogue Number: A000467
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 109