MAUDE Adverse Event Report: ATRICURE, INC. EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX; 3CM GUIDED COAG DEVICE GEN 4

Model Number CDK-1413

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

Patient Problems Pulmonary Embolism (1498); Death (1802)

Event Date 09/06/2016

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.

Event Description

Patient had surgery on (b)(6) 2016, of a convergent procedure.The surgical approach was transdiaphragmatic and the ep used a cryo balloon for pvi.The patient was apparently fine for a week and began feeling bad for four days before he called the office on (b)(6) 2016 and died later that day.The echo that was done before they pulled the drain showed no pericardial effusion.The official coroner cause of death is pulmonary embolism.

• Brand Name: EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX
• Type of Device: 3CM GUIDED COAG DEVICE GEN 4
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: ranjana iyer ; 7555 innovation way; mason, OH 45040 ; 5137555320
• MDR Report Key: 6012203
• MDR Text Key: 56909716
• Report Number: 3003502395-2016-00129
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CDK-1413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2016
• 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