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 Injury (2348)

Event Date 11/21/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation, but a device history review was obtained for lot number 97007.There is nothing in the device history record that would indicate that the devices were released with any non-conformances that would contribute to the complaint.

Event Description

It was reported that on (b)(6) 2019 a patient underwent a hybrid convergent procedure with left atrial appendage management.The ablation procedure had successful lesions with the patient converting to normal sinus rhythm by the end of the case with successful placement of a pro245 clip on the left atrial appendage.Post-op, there was a gi and thoracic consult to scope the patient and it was found that the patient had an acute burn injury in the esophagus.Out of caution, hospital protocol treatment was initiated for esophageal injury.On (b)(6) 2019 patient underwent a swallow test with no leak and as of (b)(6) 2019 patient was doing well.Patient continues to do well with additional scopes that have been performed.The patient was discharged (b)(6) 2019 in stable condition.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

• 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 ; 5136448220
• MDR Report Key: 9471172
• MDR Text Key: 187301017
• Report Number: 3011706110-2019-00061
• 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: 12/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2022
• Device Model Number: CDK-1413
• Device Catalogue Number: CDK-1413
• Device Lot Number: 97007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/18/2019
• 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 Outcome(s): Life Threatening; Required Intervention