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 07/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4) the device was not returned for evaluation but a device history review was obtained for lot number 76703.There is nothing in the device history record that would indicate that the devices were released with any non-conformance's that would contribute to the complaint.

Event Description

On (b)(6) 2018 a male patient underwent an off-pump convergent procedure with no reported procedural or device complications.The patient's anticoagulation medication was stopped 24 hours pre-op with no act being measured.Anticoagulation was restarted 24 hours post op.On (b)(6) 2018, 2 weeks post post-op, a echo was done that showed a pericardial effusion.The patient was admitted, pericardial effusion was drained with an unknown amount and the patient was discharged 2 days post drainage.Patient is doing well with ep portion of convergent procedure due to be completed in 6 weeks.

• 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: 7785681
• MDR Text Key: 117188031
• Report Number: 3011706110-2018-00197
• 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: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• 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: 76703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2017
• 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
• Treatment: RF CABLE, CANNULA
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention