MAUDE Adverse Event Report: ATRICURE INC. EPISENSE

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

Patient Problem Sudden Cardiac Death (2510)

Event Date 06/09/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).The device was not returned to atricure for evaluation as there was no indication of a device defect or malfunction, this is a adverse event only report.Adverse event, no product involvement.

Event Description

A patient underwent a successful convergent procedure on (b)(6) 2015 that expired one year later.On (b)(6) 2016 patient was admitted through er with large symptomatic hiatal hernia to be repaired.From surgery notes: (b)(6) 2016 deficit in the diaphragmatic incision from convergent surgery one year earlier.Repairs made.Patient remained in acute care, intubated, and had sepsis post surgery.Patient was then admitted to an acute long term care facility from hospital on (b)(6) 2016, remained intubated.The patient then arrested on (b)(6) 2016, brought back to er were patient expired same day.No autopsy was done.

• Brand Name: EPISENSE
• Type of Device: EPISENSE
• Manufacturer (Section D): ATRICURE INC.; 7555 innovation way; mason OH 45040
• Manufacturer (Section G): ATRICURE INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: ranjana iyer ; 7555 innovation way; mason, OH 45040
• MDR Report Key: 5954241
• MDR Text Key: 54876577
• Report Number: 3003502395-2016-00115
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120857
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2016
• 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