MAUDE Adverse Event Report: ATRICURE, INC. COOLRAIL LINEAR PEN; SURGICAL DEVICE, ABLATION CARDIAC TISSUE

Model Number MCR1

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914)

Event Date 01/29/2014

Event Type  Death  

Event Description

During a procedure on the 5th ablation, the pt began loosing pressure and was converted to on-pump.The surgeon continued ablation of the left pulmonary vein and grafting."the pt was taken off pump at completion but pressure remained low and a balloon was the pt the pt was unable to be stabilized and subsequently expired.".

Manufacturer Narrative

(b)(4).The device was not retained by the facility.Device not returned for evaluation however device history record reviewed and no non-conformance or re-work noted during manufacturing process that would be related to the reported issue.Pursuant to the surgeon, the issue was believed to be due to part to the non-typical pt anatomy which may have resulted in rf being delivered too close to the coronary artery.

• Brand Name: COOLRAIL LINEAR PEN
• Type of Device: SURGICAL DEVICE, ABLATION CARDIAC TISSUE
• Manufacturer (Section D): ATRICURE, INC.; west chester OH
• Manufacturer Contact: christina garcia ; 6217 centre park drive; west chester, OH 45069 ; 5136444232
• MDR Report Key: 3687388
• MDR Text Key: 4288003
• Report Number: 3003502395-2014-00001
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073605
• 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: 01/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Model Number: MCR1
• Device Catalogue Number: A000475
• Device Lot Number: 48082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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
• Patient Age: 63 YR