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 Problems Air Embolism (1697); Stroke/CVA (1770); Death (1802); Fistula (1862)

Event Date 07/21/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation and a device history review was unable to be completed as the relevant lot number was not reported or able to be subsequently ascertained.The complaint could not be confirmed.

Event Description

On (b)(6) 2018 a (b)(6) year old male underwent a same day, off pump epicardial and endocardial convergent procedure.On (b)(6) 2018 it was reported that the patient had presented to the er with multiple strokes and cerebral air embolism as diagnosed, based on an mri done at another hospital.Two ct scans done at (b)(6) subsequent to the mri at the initial admitting hospital did not confirm the diagnosis however, a third ct scan confirmed the original diagnosis dense stroke and signs and symptoms suggestive of an atrio-esophageal fistula, now intubated and being ventilated.The patient is currently admitted to (b)(6) with an esophageal stent placed.Neurologically the patient has been assessed as having a dense stroke and considered not a good candidate for surgery.There are no plans for immediate operation he is now being treated conservatively.

Manufacturer Narrative

(b)(4) information was received that patient was moved to hospice, expired on (b)(6) 2018.

• 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: 7782598
• MDR Text Key: 117130900
• Report Number: 3011706110-2018-00196
• 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,Followup
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• 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: 07/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 65 YR