MAUDE Adverse Event Report: ATRICURE, INC. ATRICURE BIPOLAR SYSTEM

Model Number EMR2

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

Patient Problems Death (1802); Pneumonia (2011); Pulmonary Valve Stenosis (2024)

Event Type  Death  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation, however the device history review was unable to be completed as the relevant device lot/serial number was not reported or able to be subsequently ascertained.The complaint could not be confirmed.Discarded by facility.

Event Description

On (b)(6) 2014 - total thoracoscopic tt maze, consisting of bilateral pulmonary vein isolation, with bipolar atricure clamp (left and right clamp), roof and floor lesions with atricure coolrail, ganglionated plexi ablation with atricure pen, trigone line with atricure pen, laa amputation with stapler.During endocardial touch up 3 months after the procedure severe pv stenosis of all pv's was noticed.Additionally, diagnosis was performed by ct angio.Fter extensive work-up, planned for elective cardiac surgery to explore the pericardium by sternotomy and perform a pericardectomy or pulmonary vein patch extension on all four pv's.Unfortunately after a period of pneumonia the patient suffered from severe right ventricular failure at home.Unfortunately she died in the ambulance.

• Brand Name: ATRICURE BIPOLAR SYSTEM
• Type of Device: ATRICURE BIPOLAR SYSTEM
• Manufacturer (Section D): ATRICURE, INC.; 6217 centre park drive; west chester OH 45069 3886
• Manufacturer Contact: ranjana iyer ; 6217 centre park drive; west chester, OH 45069-3886 ; 5137555320
• MDR Report Key: 5810724
• MDR Text Key: 50058496
• Report Number: 3003502395-2016-00063
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EMR2
• Device Catalogue Number: A000452
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2016
• 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