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 Sudden Cardiac Death (2510); Pericardial Effusion (3271)

Event Date 01/24/2019

Event Type  Death  

Manufacturer Narrative

(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.The complaint could not be confirmed.There were no procedural reported device malfunctions or complications.

Event Description

It was reported that a (b)(6) male patient with an ejection fraction of 30% underwent a convergent procedure in 2018.There was no reported procedural complication or device malfunction at the time of the procedure.The patient was reviewed one-month post procedure and was assessed as doing well.Three months post-procedure patient complained of chest pains and not feeling well.An ecg done at that time, revealed that he was in normal sinus rhythm but was assessed as having dressler¿s syndrome and was admitted to the hospital on that visit.An mri was performed which revealed a moderate pericardial effusion and there was no evidence of cardiac tamponade.A pericardial tap was performed, and 425cc of blood-stained fluid was drained.The patient was admitted to the hospital for 3 days and was discharged home in a stable condition.Four days post discharge, the surgeon was told by the patient¿s wife that her husband collapsed and died that same day (b)(6) 2019.The coroner stated that the patient had a sudden cardiac death.Cause of the sudden cardiac death was not communicated and an autopsy was not performed.This event is a procedure related 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 ; 5137554563
• MDR Report Key: 8358885
• MDR Text Key: 136779957
• Report Number: 3011706110-2019-00010
• 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: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CDK-1413
• Device Catalogue Number: CDK-1413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2019
• 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): Death