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 Death (1802); Perforation of Esophagus (2399)

Event Date 12/17/2018

Event Type  Injury  

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 for the epi-sense device was not reported or able to be subsequently ascertained.The complaint could not be confirmed.

Event Description

It was reported that on (b)(6) 2018 a (b)(6) female patient underwent convergent procedure.The surgical procedure seemed to go well intraoperatively; tee was clear of thrombus, circa temperature probe was placed in the esophagus and was monitored throughout the case, adhesions were present on the posterior left atrium.Ablations were performed on all viable tissue with epi-sense catheter until no more tissue on the posterior la could be reached.Patient was taken to ep lab same day where a voltage map was performed along with rf ablation touch ups near the pulmonary veins and along the roof, extensively in the right superior region of the posterior la where adhesions prohibited epicardial ablation.Procedure was completed without any known issues, patient was doing well and in sinus rhythm as of last follow up last week.Patient was brought into er two days ago ((b)(6) 2018) with gi bleeding with either of the "cardiothoraciac" surgeons being notified.Patient had an endoscopy done at the hospital, to which the now known atrio esophageal fistula was likely made much worse.Patient was brought back into the operating room later that night and aef was repaired.Patient underwent an esophagectomy earlier that morning.The patient expired the week of (b)(6) 2018.This was a procedural complication.There was no reported device malfunction.

Manufacturer Narrative

Case- (b)(4) correction made to patient information- patient age in years added.

Manufacturer Narrative

(b)(4): per additional information received, the circa probe was not used during the procedure.

• 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
• MDR Report Key: 8243764
• MDR Text Key: 132919957
• Report Number: 3011706110-2019-00005
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• PMA/PMN Number: K142084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2019
• 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
• Date Manufacturer Received: 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 80 YR