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

Model Number CDK-1413AF

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

Patient Problem Pericardial Effusion (3271)

Event Date 02/26/2016

Event Type  Injury  

Manufacturer Narrative

Case (b)(4) the device was not returned for evaluation but a device history review was obtained for lot number af271401.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) 2016 that a (b)(6) male patient had an off-pump convergent study procedure.Patient was heparinized with 19,890 units.On post-op day 16, (b)(6) 2016, subject presented to outpatient office complaining of fatigue and dyspnea on exertion.A transthoracic echocardiogram was performed showing medium to large pericardial effusion.The subject was transferred to the emergency room where he was evaluated and admitted.On (b)(6) 2016, a pericardial window was performed and a chest tube was inserted and later discharged from hospital.This event has previously been reported to the agency under ide study (b)(4).This event has been adjudicated as a procedural issue as part of the ide study (b)(4).Although this event has not been attributed to the device, atricure is reporting this event under part 806.

• 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: 7790334
• MDR Text Key: 117345202
• Report Number: 3011706110-2018-00198
• 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: 08/16/2018

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: 12/31/2016
• Device Model Number: CDK-1413AF
• Device Catalogue Number: CDK-1413AF
• Device Lot Number: AF271401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2016
• Initial Date FDA Received: 08/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2014
• 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: GERERATOR, CANNULA
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 105