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

Model Number CDK-1413

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

Patient Problem Death (1802)

Event Date 05/29/2018

Event Type  Death  

Manufacturer Narrative

(b)(4) the device was not returned for evaluation but a device history review was able to be obtain from the lot number given in the product information.

Event Description

On (b)(6) 2018, a (b)(6) female patient underwent an off-pump staged sub-xiphoid approach convergent surgical procedure using epi-sense device.Patient was not heparinized during procedure.Patient was discharged from the hospital.Patient did not show-up for follow-up visit/ep procedure.After hospital contact, it was made aware that while the patient was on a trip to (b)(6), the patient passed away.Patient expired on (b)(6) 2018 but it is still undetermined as to what the patients official cause of death is.

• 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 ; 7555 innovation way; mason, OH 45040
• MDR Report Key: 7655900
• MDR Text Key: 112933336
• Report Number: 3011706110-2018-00180
• 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: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Model Number: CDK-1413
• 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: 06/09/2018
• 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
• Treatment: CANNULA
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 72