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

Model Number EPI-SENSE

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

Patient Problem Stroke/CVA (1770)

Event Date 02/09/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was discarded by the facility, there was no indication of a device defect or malfunction.

Event Description

A convergent procedure was performed on (b)(6) 2017, without incident.It was noted that cryo and rf technologies were used and that no clip was placed.Information from the physician was that the patient had a history of stroke and was hypercoagulative.Pt was cardioverted in the ep lab to nsr and extubated then transferred to icu as per hospital protocol.On day 2 after surgery, the patient was on the medical surgical floor when he became unresponsive.He was taken to the operating room (or) for an emergency craniotomy which showed a" shower of clots was found." as of (b)(6) 2017 the patient was moving all extremities and responding appropriately to commands.It was also noted that the patient was not given his dose of xarelto.

• 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; cincinnati OH 45040 0000
• Manufacturer Contact: ranjana iyer ; 7555 innovation way; cincinnati, OH 45040-0000 ; 5137555328
• MDR Report Key: 6401117
• MDR Text Key: 69822843
• Report Number: 3003502395-2017-00030
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: EPI-SENSE
• Device Catalogue Number: CDK-1413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2017
• 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): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 61 YR