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); Tissue Damage (2104)

Event Date 09/10/2014

Event Type  Death  

Event Description

It was reported that after vein isolation and testing with the emr2 and max5 the mcr1 was used to start ablating the superior left atrium.After a few 40 second burns the pt's blood pressure started to drop with subsequent morphology changes in the ecg.Thereafter the tee was performed to verify activity changes in the left ventricle and the decision was made to perform a median sternotomy.After opening the patient it was observed that the mcr1 had extended across and ablated the left coronary artery (circumflex).The patient expired on (b)(6) 2014.

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 patient 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: 4172346
• MDR Text Key: 20975610
• Report Number: 3003502395-2014-00013
• 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: 09/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• 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
• Device Lot Number: 40983
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/11/2014
• 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