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 11/28/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation as there were no device complaints or malfunctions, it was a procedural complication.A device history review was unable to be completed as the relevant device lot/serial number was not reported or able to be subsequently ascertained.

Event Description

On (b)(6) 2017, a (b)(6) female underwent a staged convergent procedure with the sub-xiphoid approach with the ep portion to be done later.The procedure was uneventful and there were no product malfunctions or complaints.Day 2 post op, the patient became hypotensive, hypoxic, and imaging showed a right pleural effusion and was intubated.For the next couple of days, patient remained unstable requiring inotropic support, blood results revealed elevated wbcs and showed signs of sepsis.Day 7 post op, a ct scan with po contrast showed esophageal perforation.The patient underwent exploratory thoracotomy.The esophagoscopy findings were a full thickness necrosis of the esophagus.The microscopy findings were a segment of esophagus with transmural necrosis, acute and chronic inflammation, and epithelial reactive changes.Day 9 post op, the patient became bradycardic and died.There were no product malfunctions, this was a procedural complication.

Manufacturer Narrative

Section was entered as the incorrect date of event, information has been corrected to (b)(6) 2017.

• 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: anupam bedi
• MDR Report Key: 7164786
• MDR Text Key: 96385351
• Report Number: 3011706110-2018-00111
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Model Number: CDK-1413
• Device Catalogue Number: CDK-1413
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2017
• 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): Death
• Patient Age: 70 YR
• Patient Weight: 75