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 Death (1802); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 07/11/2019

Event Type  Death  

Manufacturer Narrative

Case-(b)(4).The device was not returned for evaluation and the device history review was unable to be completed as the relevant device lot/serial number was not reported or able to be ascertained.

Event Description

It was reported on (b)(6) 2019 that on (b)(6) 2019 a male patient underwent the epicardial portion of a convergent procedure.On (b)(6) 2019, the patient presented to the er and was diagnosed with pericardial effusion.The patient was admitted, 500 cc of serous-sanguineous fluid was tapped, was started on medications and a pleural drain was put in place.On (b)(6) 2019 output was down to 225 cc per day.The drain was removed on (b)(6) 2019.An echocardiogram on (b)(6) 2019 showed only a trace of fluid, the patient was discharged home on (b)(6) 2019.On (b)(6) 2019 the patient presented to the er with tamponade symptoms, was admitted, and taken to operating room.The pericardium was opened, clear fluid was drained, and pleural drain was placed.The patient was placed on iv steroids, colchicine, toradol.The patient is in recovery.This was a procedural complication.There was no reported device malfunction.

Manufacturer Narrative

(b)(4) follow up report: it was reported on (b)(6) 2019, patient health continued to decline until patient expired on (b)(6) 2019.It was also reported that the patient had hepatitis c and had just finished a round of experimental medication.

• 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
• MDR Report Key: 8878563
• MDR Text Key: 153813233
• Report Number: 3011706110-2019-00037
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• PMA/PMN Number: K142084
• 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: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention