MAUDE Adverse Event Report: ATRICURE, INC. EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX

Model Number EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Great Vessel Perforation (2152)

Event Type  Death  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation as there was no report of any product malfunction and no product history review was done as well.

Event Description

A male patient had an off-pump convergent hybrid maze procedure on (b)(6) 2017.The patient was off-pump and was heparinized during the procedure.The epi-sense device and st.Jude ep catheter was used.At some point, post-procedure, an esophageal fistula and stroke occurred.Atricure was alerted to this adverse event on (b)(6) 2017.On follow-up with the facility, the patient is still currently in the hospital at an in-patient rehab facility.

Manufacturer Narrative

Case (b)(4) per additional information obtained patient had ep portion of convergent procedure 24 hours after initial surgery, 3 weeks later the patient presented to the hospital on an unknown date and was diagnosed as having an aef and then had a stroke.The patient died, date unknown.

• 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: 6792116
• MDR Text Key: 82618374
• Report Number: 3011706110-2017-00071
• 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: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Model Number: EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS
• 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: 07/20/2017
• 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: N
• Patient Sequence Number: 1
• Treatment: EP CATHETERS ST. JUDE.
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention