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 Pleural Effusion (2010)

Event Date 12/09/2019

Event Type  Injury  

Manufacturer Narrative

Case (b)(4).The device was not returned for evaluation, but a device history review was obtained for lot number 91616.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 on 18-dec-2019, that a (b)(6) female patient who was enrolled in the deep clinical study, underwent the epicardial portion of the procedure on (b)(6) 2019.On post-op day 6 the patient experienced a pleural effusion.The patient was prescribed medication (bumex) and discharged.During a follow-up visit on (b)(6) 2019, patient was still experiencing shortness of breath and taking medications.A thoracentesis was performed on (b)(6) 2019 and 800ml of serous fluid was drained.A chest x-ray confirmed the pleural effusion was resolved.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

• Brand Name: COOLRAIL LINEAR PEN
• Type of Device: COOLRAIL LINEAR PEN
• 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: 9597854
• MDR Text Key: 178352517
• Report Number: 3011706110-2020-00002
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/16/2020

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: 12/01/2021
• Device Model Number: MCR1
• Device Catalogue Number: A000625
• Device Lot Number: 91616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2019
• Initial Date FDA Received: 01/16/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/31/2018
• Is the Device Single Use?: No
• 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