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 Air Embolism (1697); Death (1802); Fistula (1862)

Event Type  Injury  

Manufacturer Narrative

Complaint number: (b)(4).The device was not returned for evaluation, however the device history review was unable to be completed as the relevant device lot/serial number was not reported or able to be subsequently ascertained.The complaint could not be confirmed.Device discarded by facility.

Event Description

The patient underwent pvi by her cardiologist.Partly successful.Followed by multiple cardioversions.In the last days of (b)(6) 2014 the patient underwent a thoracoscopic rfa treatment of the left atrium.(vats maze rfa) with the use of the atricure clamp device and the coolrail device.The left auricle was amputated with a stapler.The patient was discharged in (b)(6) from the hospital on day seven after one new ecv because of a single new period of aflutter.The patient was acutely readmitted during four weeks later to the neurology ward in our hospital with neurological deficit, a stroke.On the next day the patient had progressive signs of neurological deficit.A ct scan showed air in the left ventricle of the heart and ascending aorta.Neurological deficit progressed.She died in the evening.Unfortunately no post mortem investigations were done.

• 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 ; 5137555320
• MDR Report Key: 5940817
• MDR Text Key: 54397338
• Report Number: 3003502395-2016-00099
• 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: Other
• Type of Report: Initial
• Report Date: 08/11/2016

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: Health Professional
• Device Model Number: MCR1
• Device Catalogue Number: A000475
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/11/2016
• Initial Date FDA Received: 09/09/2016
• 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
• Treatment: ATRICURE CLAMP
• Patient Outcome(s): Death; Hospitalization; Disability
• Patient Age: 66 YR