MAUDE Adverse Event Report: ATRICURE, INC. COOLRAIL LINEAR PEN

Model Number MCR1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombus (2101)

Event Date 11/06/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned to atricure for evaluation as it was implanted.The device history record was reviewed and no non-conformances or re-works were noted during manufacturing process that would be related to the reported issue.Device implanted.

Event Description

Patient underwent a thoracoscopic left atrial epicardial maze procedure with left atrial appendage exclusion using atricure atriclip for treatment of atrial fibrillation.On pod (2), patient subject experienced brief 10 minute episode of slurred speech with right sided weakness coinciding with hypertensive episode which completely resolved, with no residual defect.A head ct without iv contrast showed no evidence of hemorrhage, mass effect or midline shift, axial fluid collection or acute infarct.The peripheral vascular lab exam (pvl) of bilateral upper extremities examined using duplex ultrasound, showed no evidence of deep venous thrombosis in the upper bilateral extremities.Patient was discharged in stable condition.The surgeon does not believe any of atricure device malfunctioned.

Manufacturer Narrative

Complaint number (b)(4): the safety adjudication review concluded the primary relationship to the device.The device was not returned to atricure for evaluation.The device history record was reviewed and no nonconformances or re-works were noted during manufacturing process that would be related to the reported issue.Discarded by facility.

• Brand Name: COOLRAIL LINEAR PEN
• Type of Device: COOLRAIL LINEAR PEN
• Manufacturer (Section D): ATRICURE, INC.; 6217 centre park drive; west chester OH 45069 3886
• Manufacturer Contact: ranjana iyer ; 6217 centre park drive; west chester, OH 45069-3886 ; 5137555320
• MDR Report Key: 5710489
• MDR Text Key: 47119244
• Report Number: 3003502395-2016-00017
• 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: study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• 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: 57672-12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/06/2015
• 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): Hospitalization; Other