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); Fistula (1862); Thrombus (2101)

Event Date 03/07/2016

Event Type  Death  

Manufacturer Narrative

Complaint number: (b)(4).The device was not returned for evaluation.A 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.

Event Description

As part of deep clinical study, (b)(6) 2016, a (b)(6) female, underwent a bilateral thoracoscopic epicardial maze procedure with pvi and left atrial appendage exclusion using atricure atriclip for treatment of long standing atrial fibrillation.Subject's post-operative course was uneventful.On (b)(6) 2016 pod (22) after experiencing shortness of breath, palpitation and fatigue subject presented to er and was started on iv dofetilide.On (b)(6) 2016 the subject was found unresponsive and exhibiting pulseless electrical activity.The subject was emergently intubated and later underwent cardiac catheterization.On (b)(6) 2016, the subject was cardioverted under sedation to correct persistent atrial fibrillation; sinus rhythm was restored.On (b)(6) 2016 she experienced gi bleed.Head ct revealed large bilateral posterior coronary artery territory infarcts.Diagnosis of bilateral stroke.Chest ct revealed a small focus of air within the posterior mediastinum in the region of the posterior wall of the left atrium.The subject status was changed to dnr.On (b)(6) 2016 life support was withdrawn.Post-mortem report revealed an atrio-esophageal fistula, from complications of the cardiac ablation procedure which was performed in effort to control persistent atrial fibrillation.Death resulted from massive cerebral insult with global cerebral edema and ischemic encephalopathy due to air emboli which gained vascular access via the left atrio-esophageal fistula.

Manufacturer Narrative

(b)(4).The device lot number was ascertained.During the device history review, there was nothing to indicate that the device had any nonconformities that would have contributed to the complaint.

• 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: 5577753
• MDR Text Key: 42679764
• Report Number: 3003502395-2016-00018
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2016
• 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: 56240-06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2016
• 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
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Other
• Patient Age: 60 YR