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 02/21/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The episense device lot number 87117 was returned and evaluated.The complaint was confirmed for zero flow within the flow limiter at the perfusion port.There was no adverse event reported.

Event Description

It was reported on (b)(6) 2019 that a patient underwent a convergent procedure.Patient was off-pump and heparinized.During the procedure, the temperature on the temperature probe suddenly rose up to 40c.After cooling down for another lesion; the event happened again.It was recognized that the saline perfusion through the device was not working properly.The probe was exchanged for a new device and the procedure was completed.There were 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: 8543898
• MDR Text Key: 142930288
• Report Number: 3011706110-2019-00023
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2021
• Device Model Number: CDK-1413
• Device Catalogue Number: CDK-1413-EU
• Device Lot Number: 87117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2018
• 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