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

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

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

Patient Problem Death (1802)

Event Date 08/22/2017

Event Type  Death  

Manufacturer Narrative

(b)(4): no device returned.Product history review could not be performed due to no serial and/or lot information reported.No product malfunction reported during the incident.

Event Description

A (b)(6) male patient received a staged convergent subxiphoid procedure performed on (b)(6) 2017.The patient had a normal lv systolic function with normal ef.His ef was 55-60% in (b)(6) 2017 and 65-70% on the echos that he had done when he was in the hospital after the convergence procedure.His mitral valve was normal in the (b)(6) 2017 echo.Anti-coagulation therapy was administered during the initial procedure and the act was measured.The ep portion of the procedure was not performed.The patient had renal failure post-procedure.Creatinine levels were measured at baseline of 2.1 and elevated to 7.2.The patient coded six (6) days post-operation and was revived.A large pericardial effusion was diagnosed on an echo and patient was scheduled to have a window, but expired prior to surgery.A chest x-ray was done and did not show any significant pleural effusion.The patient died six (6) days post-operation while still in the hospital on (b)(6) 2017.No device malfunction was reported during the procedure.

• Brand Name: EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS
• Type of Device: EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS
• 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: 6864271
• MDR Text Key: 86090297
• Report Number: 3011706110-2017-00080
• 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
• Report Date: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 08/22/2017
• Initial Date FDA Received: 09/14/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 76 YR