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 Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 04/21/2018

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 73597.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) 2018, that a (b)(6) - year- old female patient had an off-pump convergent study procedure.On post-op day two, patient complained of shortness of breath on exertion.Patient treated with lasix and echocardiogram showed no pericardial effusion.Patient was discharged.On post-op day 20, (b)(6) 2018, patient visited for a post procedure transthoracic echocardiography (tte) and presented with complaints of shortness of breath, fatigue and cough.Tte result showed moderate pericardial effusion.Patient sent to the emergency room and was admitted with pericardial effusion concerning for tamponade.On (b)(6) 2018, the subject underwent sub-xiphoid pericardial window procedure.A large, bloody effusion was drained, and a right-angled chest tube was placed in the pericardial space.The subject was transferred out of the operating room in stable condition and later discharged.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: 7790696
• MDR Text Key: 117420790
• Report Number: 3011706110-2018-00201
• 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: 04/30/2020
• Device Model Number: CDK-1413
• Device Catalogue Number: CDK-1413
• Device Lot Number: 73597
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2018
• Initial Date FDA Received: 08/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2017
• 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
• Patient Age: 57 YR
• Patient Weight: 90