MAUDE Adverse Event Report: ATRICURE, INC. EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX

Model Number CDK-1413

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

Patient Problems Dyspnea (1816); Pleural Effusion (2010); Pericardial Effusion (3271)

Event Date 08/13/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported on 14-aug-2020 that on (b)(6) 2020 a patient underwent a staged convergent epicardial ablation with left atrial appendage management procedure.The procedure was completed without any device malfunction or complication.The patient was discharged on xarelto and colchicine after his initial procedure.Four weeks post-procedure on (b)(6) 2020, the patient complained of shortness of breath and was readmitted to the hospital.A chest-ray revealed left pleural effusion, additional investigation revealed a significant pericardial collection which required urgent surgical intervention.The patient underwent a left anterior mini thoracotomy draining fluid from both the pericardium and the left pleural cavity.The intervention resulted in a resolution and an improvement in the patient¿s condition.This was a procedural complication.There was no reported device malfunction.

• Brand Name: EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX
• Type of Device: EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX
• 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: 10566096
• MDR Text Key: 207902975
• Report Number: 3011706110-2020-00030
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142084
• 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: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDK-1413
• Device Catalogue Number: CDK-1413
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2020
• 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
• Treatment: PRO245
• Patient Outcome(s): Life Threatening; Required Intervention