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

Model Number EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS

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

Patient Problem Pericardial Effusion (3271)

Event Date 07/28/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned to atricure for evaluation.The device history review does not indicate that the manufactured lot was released with any non-conformances that would have contributed to the event.There was no reported device malfunction associated with this event.

Event Description

A patient enrolled in the converge study had a subxiphoid convergent procedure completed for persistent atrial fib on (b)(6) 2017.There was nothing outstanding about the procedure and patient was discharged post-op day 2 with an echocardiogram on that day revealing no pericardial effusion.On (b)(6) 2017, the patient presented to the ed with progressive 3-day history dyspnea, weakness, and dizziness.He underwent a stat echocardiogram revealing a significant pericardial effusion.He was admitted and underwent a pericardial window that drained in excess of fluid.Patient was discharged on (b)(6) 2017.

• 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: anupam bedi
• MDR Report Key: 6814226
• MDR Text Key: 83421923
• Report Number: 3011706110-2017-00074
• 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: 08/22/2017

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: Other Health Care Professional
• Device Expiration Date: 01/01/2020
• Device Model Number: EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS
• Device Catalogue Number: CDK-1413
• Device Lot Number: 71332
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2017
• Initial Date FDA Received: 08/23/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/16/2017
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 125