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); Perforation of Esophagus (2399)

Event Date 10/31/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).The device was not returned to atricure for evaluation as there was no report of a malfunction, no indication of a device defect.

Event Description

The patient had the bilateral thoracoscopic left atrial maze procedure on (b)(6) 2016.There was no unusual anatomy or deviation from the routine surgical technique and equipment including the atricure clamp, pen, and the coolrail.In retrospect following the patient's presentation, the surgeon recalls the anesthesia team had the transesophageal probe within the esophagus and resident/fellow using the probe to image the heart.This is not routine for this procedure and it was not noted by the surgeon until later in the case.There were no specific issues that the surgeon could recall with the equipment during the case.The patients postoperative recovery was unremarkable and she had a follow up appointment in the clinic approximately 4 weeks later.She had no specific complaint and was feeling well and doing well.She presented few days later to the hospital with stroke symptoms and found to have an atrial-esophageal fistula.Unfortunately, the patient did not survive despite aggressive measures to correct the injury.The patient was quite healthy and no comorbidities to account for the injury.

• Brand Name: COOLRAIL LINEAR PEN
• Type of Device: COOLRAIL LINEAR PEN
• Manufacturer (Section D): ATRICURE INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: ranjana iyer ; 7555 innovation way; mason, OH 45040 ; 5137555328
• MDR Report Key: 6356800
• MDR Text Key: 68264825
• Report Number: 3003502395-2017-00027
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Initial Date Manufacturer Received: 01/30/2017
• Initial Date FDA Received: 02/24/2017
• 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): Death; Life Threatening; Other