MAUDE Adverse Event Report: ATRICURE, INC. EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX

Model Number CDK-1413

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

Patient Problems Death (1802); Pleural Effusion (2010); Pericardial Effusion (3271)

Event Date 11/10/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation as this adverse event occurred post-operation.No product history review was able to be performed as no lot number was reported for this device.There was no device malfunction reported during the initial procedure.

Event Description

On (b)(6) 2017, a (b)(6) male patient received an off-pump convergent epicardial/endocardial ablation procedure using an episense guided coagulation system (cdk-1413) and the patient was discharged on (b)(6) 2017.On (b)(6) 2017, the patient presented to the er with shortness of breath, peripheral edema and chest pain.The patient¿s chest x-ray was clear with no pleural effusion.However, a ct scan performed revealed small left and trace right pleural effusion, with small pericardial effusion.The patient was placed under observation, treated with an iv diuretic and discharged with major improvement in condition.On (b)(6) 2017, an echo performed on the patient showed no pericardial or pleural effusion.On (b)(6) 2017, the patient returned to his primary care physician who reported an ef 55%, and the patient was directed to consult with the cardiac surgeon on administration of medicine.The diuretic was increased to 80mg for the day, and then returned to 40mg/day.On (b)(6) 2017, the patient returned to the er presenting with afib and chf exacerbation.His white cell blood count was 19.7 and chest x-ray indicated his lungs were clear and unremarkable.The patient was kept in the hospital overnight for observation.On (b)(6) 2017, while being prepared for cardioversion, the patient stopped breathing, lost pulse, and was unresponsive.After unsuccessful attempts at reviving, the patient passed away on (b)(6) 2017.

• Brand Name: EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX
• Type of Device: EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer (Section G): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: anupam bedi
• MDR Report Key: 7110247
• MDR Text Key: 94573334
• Report Number: 3011706110-2017-00104
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Model Number: CDK-1413
• Device Catalogue Number: CDK-1413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2017
• 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
• Patient Age: 69 YR
• Patient Weight: 160