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 06/10/2019

Event Type  Injury  

Manufacturer Narrative

(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 (b)(6) 2019, that a (b)(6) male patient, who was enrolled in (b)(6) clinical study, underwent an epicardial portion of the procedure on (b)(6) 2019 and was discharged from the hospital on (b)(6) 2019.During a follow-up visit on (b)(6) 2019, patient presented with significant fluid retention.An ultrasound was conducted which revealed pleural effusion.The patient was prescribed medication bumex 1 mg.On (b)(6) 2019, the patient presented with weight loss and complained of shortness of breath when walking.A thoracentesis was performed, 1000 ml serosanguineous fluid was drained.The surgeon assessed the adverse event of pleural effusion as related to patient¿s intercurrent condition and not related to the device or procedure.Current status of the patient, the pleural effusion is resolved, and the patient is doing well.This is a procedure related complication.There was no reported device malfunction.

• 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 ; 5137554563
• MDR Report Key: 8771808
• MDR Text Key: 150542826
• Report Number: 3011706110-2019-00034
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122611
• 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: 07/09/2019

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 Model Number: MCR1
• Device Catalogue Number: A000719
• Device Lot Number: 91616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/11/2019
• Initial Date FDA Received: 07/09/2019
• 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: 75 YR