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

Model Number CDK-1413

Device Problem No Flow (2991)

Patient Problem No Patient Involvement (2645)

Event Date 03/14/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4) the epi-sense device lot number 88524 was returned and evaluated.The complaint was confirmed for zero flow within the flow limiter at the perfusion port.

Event Description

It was reported that on (b)(6) 2019 a patient underwent a convergent procedure with left atrial appendage management.Upon initial set up of the epi-sense device, the saline drip was hooked up to the tear drop on the device and suction turned on, but no saline was pulling through the system.The connections to the device was confirmed, the saline was unhooked from the device, confirmed saline flow through tubing and reapplied tubing to device.Once again, there was no saline flow and at that point, the epi-sense device was exchanged out for a new device using the same tubing as before.The new epi-sense device functioned normally and the procedure was completed.The case was delayed one minute to troubleshoot and change out the device.The procedure was completed as anticipated with no adverse effects on the patient.

• 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: 8511108
• MDR Text Key: 145526203
• Report Number: 3011706110-2019-00017
• 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: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2021
• Device Model Number: CDK-1413
• Device Catalogue Number: CDK-1413
• Device Lot Number: 88524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2018
• 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