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); ST Segment Elevation (2059); Ventricular Tachycardia (2132)

Event Date 12/28/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2020 a (b)(6) year-old male with a history of persistent afib underwent an off-pump convergent procedure with left sided tt and laam.After the convergent portion of the procedure was complete and the surgeon was inserting the blake drain through the subx incision the patient immediately showed st elevation.The patient stabilized and the surgeon completed the left sided tt and the laa with a pro240.When the patient was transferred from the or table to the bed the patient went back into st elevation.They shocked the patient and immediately transferred the patient to the catheterization lab.By the time the patient got to the cath.Lab, the patient went into vf they proceeded to try and cardiovert the patient.The patient ultimately arrested and expired.This was a procedural complication and there was no reported device malfunction.

• 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: john ehlert ; 7555 innovation way; mason, OH 45040 ; 5136448220
• MDR Report Key: 11233154
• MDR Text Key: 228798013
• Report Number: 3011706110-2021-00003
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193162
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2020
• 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