MAUDE Adverse Event Report: ATRICURE INC. COOLRAIL LINEAR PEN

Model Number MCR1

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

Patient Problems Death (1802); Thrombus (2101)

Event Date 10/16/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).No device defects or malfunctions occured during the procedure, therefore, the device was discarded by the facility after the case.The device was not returned to atricure for evaluation and the lot number of the device was unable to be ascertained.The device was discarded by facility.

Event Description

It was reported by the rep after speaking with the surgeon on (b)(6) 2015, the surgeon informed him that after a minimally invasive tt procedure, performed on (b)(6) 2015, the patient experienced an esophageal fistula.The left inferior pulmonary vein was fused to the esophagus.As a result of the fistula, the patient also experienced a tia.The fistula was repaired, and the surgeon reported that the patient is now doing well and recovering.The patient was off pump and was not heparinized.

Event Description

Through subsequent follow up via the clinical development director and the surgeon in november 2016, it was reported that the patient had expired due to complications of the aef that was originally reported in dec 2015.

• Brand Name: COOLRAIL LINEAR PEN
• Type of Device: COOLRAIL LINEAR PEN
• Manufacturer (Section D): ATRICURE INC.; 7555 innovation way; mason OH 45040 3886
• Manufacturer Contact: ranjana iyer ; 7555 innovation way; mason, OH 45040-3886 ; 5137555328
• MDR Report Key: 5311242
• MDR Text Key: 33889933
• Report Number: 3003502395-2015-00050
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122611
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 11/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: MCR1
• Device Catalogue Number: A000475
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/03/2015
• 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; Hospitalization; Life Threatening; Required Intervention