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 Chest Pain (1776)

Event Date 01/08/2023

Event Type  Death  

Manufacturer Narrative

Case: (b)(4).The device was not returned for evaluation and a device history review was unable to be completed as the relevant lot number for the epi-sense device was not reported or able to be subsequently ascertained.

Event Description

On (b)(6) 2022, a patient underwent the epicardial portion of a convergent procedure.Patient stay was uneventful, and the patient was discharged as expected.Physician followed best practices for outpatient post-op medical management per the product ifu.On (b)(6) 2023, patient presented to another hospital emergency department with chest discomfort.An esophagogastroduodenoscopy (egd) was ordered and completed.Egd study resulted in an immediate blood entry into the esophagus.The location of the esophageal blood entry is unknown at this time.Emergency surgery was performed, but the patient ultimately expired.It is unknown if an autopsy has been performed.As atricure is unable to rule out a potential contribution from the ablation procedure, this event is being reported per part 803.There was no reported device malfunction, and the 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: 16321210
• MDR Text Key: 309020744
• Report Number: 3011706110-2023-00005
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CDK-1413
• Device Catalogue Number: CDK-1413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2023
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: CIRCA TEMP PROBE
• Patient Outcome(s): Death
• Patient Sex: Female