MAUDE Adverse Event Report: ATRICURE, INC. COOLRAIL LINEAR PEN

Model Number MCR1

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

Patient Problem Cardiac Perforation (2513)

Event Date 12/14/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The mcr1 device was not returned for evaluation, but a device history review was obtained for lot number 103090.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.

Event Description

It was reported that on (b)(6) 2020 a patient underwent a thoracoscopic maze procedure.The physician was ablating with the mcr1 device on the left side in-between the left superior pulmonary vein and the left atrial appendage and a perforation occurred that resulted in bleeding that required converting the procedure to an open sternotomy.The patient was stabilized, and put-on bypass to repair the area of tissue with sutures.The lesion set was completed, and patient weaned off bypass.Patient stabilized post-procedure and was discharged.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

Manufacturer Narrative

(b)(4).The mcr1 device, lot number 103090, was returned for evaluation and visually and functionally tested.The device passed all inspection criteria and the functional check, there was not malfunction of the device.

• Brand Name: COOLRAIL LINEAR PEN
• Type of Device: COOLRAIL LINEAR PEN
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• MDR Report Key: 11100312
• MDR Text Key: 224807493
• Report Number: 3011706110-2020-00035
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• PMA/PMN Number: K190587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2023
• Device Model Number: MCR1
• Device Catalogue Number: A000475-4
• Device Lot Number: 103090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 12/31/2020
• Supplement Dates Manufacturer Received: 12/14/2020
• Supplement Dates FDA Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention