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 10/27/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).The device was not returned to atricure for evaluation.The lot number of the device(s) was unable to be ascertained.Device discarded by facility.

Event Description

Patient underwent a totally thoracoscopic cardiac tissue ablation on (b)(6) 2016 and there were no complications.All devices performed as expected, patient was off pump and not heparinized for this procedure.Approximately 30 days later, the patient presented to er and was admitted.While admitted patient experienced stroke.On (b)(6) 2016 patient expired from issues resulting from stroke which the doctor believes were a result from air getting into the heart due to aef.

• 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: 6159691
• MDR Text Key: 62074005
• Report Number: 3003502395-2016-00172
• 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: 11/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• 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
• 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: EML; EMR2; MAX5; MID1; PRO2
• Patient Outcome(s): Death; Other
• Patient Age: 55 YR