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 Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 05/10/2021

Event Type  Injury  

Manufacturer Narrative

Case (b)(4) the epi-sense device was not returned for evaluation and a device history review was unable to be completed as the relevant lot number for the epi-sense device was not reported or able to be subsequently ascertained.

Event Description

It was reported on (b)(6) 2021 that on (b)(6) 2021 a (b)(6) year-old male patient underwent an off-pump convergent and lariat device placement procedure.There were no reported procedure or device complications.Two-weeks post-op, the patient presented with chest pain which was diagnosed as symptomatic tamponade.An echocardiogram showed a pericardial effusion and arrested while patient being prepped for surgery.The physician performed a sternotomy and stated there was swelling and blood and drained 400cc of bloody fluid.Patient is now doing well.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

Event Description

Additional information received: effusion was due to a laceration of the left internal mammary artery from an unknown source.The bleeding was controlled, but a thrombus formed that compressed the right ventricle, thus a sternotomy was performed to debride the thrombus.

• 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
• MDR Report Key: 12068622
• MDR Text Key: 264772358
• Report Number: 3011706110-2021-00033
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• PMA/PMN Number: K193162
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CDK-1413
• Device Catalogue Number: CDK-1413
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/01/2021
• Initial Date FDA Received: 06/25/2021
• Supplement Dates Manufacturer Received: 06/01/2021
• Supplement Dates FDA Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LARIAT DEVICE
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 71 YR