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

Model Number CDK-1413

Device Problem Obstruction of Flow (2423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4) the episense device - lot number 88524 was returned for evaluation.Upon evaluation, it was confirmed that there was zero perfusion / flow meter was at: 0.Perfusion did not work.There was no reported patient injury or procedural complications reported.

Event Description

It was reported that on (b)(6) 2019 a patient underwent a convergent procedure where the patient was not on-bypass and not heparinized.During setup of the episense device, a failure was observed with the irrigation saline.The saline was not functioning when hooked up to the ¿tear drop¿ on the device.All connections were double checked, disconnected and reconnected without success.After a minute of retrying the connections, it was decided to open a new episense device which worked without issue.The faulty device was not inserted into the patient¿s body and no significant time was lost during this change out of device.There was no patient impact and no concerns were expressed related to this malfunction.The procedure was completed with the new episense device.There were no reported procedural complications.

• 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: 8411483
• MDR Text Key: 142387284
• Report Number: 3011706110-2019-00011
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 01/28/2019
• Initial Date Manufacturer Received: 02/11/2019
• Initial Date FDA Received: 03/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2018
• 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