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 03/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The episense 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 (b)(6) year old male patient underwent a convergent epicardial ablation procedure.Prior to the start of the procedure, the staff tested the device and the saline would not channel through the device when suction was on.When saline was detached from the device, saline would flow without issue.The staff tried flushing the probe with saline through the flush port and it would not flush.A new probe and radio frequency cable were opened, and the procedure was completed with the new device set-up.The procedure was completed with no adverse consequence to 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: 8519851
• MDR Text Key: 147621903
• Report Number: 3011706110-2019-00019
• 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: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• 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: 04/08/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2019
• 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
• Patient Age: 51 YR