MAUDE Adverse Event Report: ATRICURE, INC. COOLRAIL LINEAR PEN ELECTROSURGERY DEVICE; SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE, INCLUDING

Model Number UNKNOWN

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

Patient Problems Sepsis (2067); Dizziness (2194); Loss of consciousness (2418)

Event Date 09/17/2021

Event Type  Death  

Event Description

Patient underwent an aortic valve replacement, aortic stenosis and a modified maze procedure for paroxysmal atrial fibrillation on (b)(6) 2021.The open heart surgery was uncomplicated and patient was discharged on (b)(6) 2021 in stable condition.Patient attended to 2 post-op visits, healing well with no complaints on (b)(6) 2021.Patient presented to the emergency department on (b)(6) 2021 after an episode of dizziness and temporary unconsciousness at a local restaurant.Patient was intubated and flown via (b)(6) to a higher level of care.On (b)(6) 2021 the original cardiovascular surgeon noted on the electronic health record that the patient had passed away due to sepsis from atrioesophageal fistulation; speculating that the fistula was caused by the device in question.Fda safety report id# (b)(4).

• Brand Name: COOLRAIL LINEAR PEN ELECTROSURGERY DEVICE
• Type of Device: SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE, INCLUDING
• Manufacturer (Section D): ATRICURE, INC.
• MDR Report Key: 12711196
• MDR Text Key: 279011963
• Report Number: MW5104978
• Device Sequence Number: 1
• Product Code: OCL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: MCR1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 50 YR
• Patient Weight: 127