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 Problem Pericardial Effusion (3271)

Event Date 08/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.However, a device history review was obtained for lot number 82627.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 23aug2018 that a (b)(6) male patient who was enrolled in (b)(6) clinical study underwent study procedure on (b)(6) 2018.Post-operative echocardiogram done on (b)(6) 2018 showed no pericardial effusion.Patient reportedly developed a persistent dry cough several days following the study procedure and cardioversion.The cardiologist ordered a chest x-ray and echocardiogram on (b)(6) 2018.The echocardiogram results revealed a large circumferential pericardial effusion measuring 2.1 cm posteriorly and 1.3 cm anteriorly.The patient was admitted to the hospital.Patient denied they had symptoms of dyspnea, fatigue, peripheral edema, and chest pain.The patient was hemodynamically stable with no clinical signs of cardiac tamponade.On (b)(6) 2018 a pericardial window and cardioversion was performed.The patient converted to sinus rhythm and was discharged on (b)(6) 2018 in stable condition.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 ; 5136448220
• MDR Report Key: 7890255
• MDR Text Key: 120760415
• Report Number: 3011706110-2018-00210
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/19/2018

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: 08/01/2020
• Device Model Number: CDK-1413
• Device Catalogue Number: CDK-1413
• Device Lot Number: 76539
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2018
• Initial Date FDA Received: 09/19/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/16/2017
• 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: 55 YR
• Patient Weight: 106