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 Bradycardia (1751); Ventricular Flutter (2131)

Event Date 11/26/2018

Event Type  Injury  

Manufacturer Narrative

Case-(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 epi-sense device was not reported or able to be subsequently ascertained.The complaint could not be confirmed.

Event Description

It was reported that on (b)(6) 2018 a male patient underwent a convergent procedure with epicardial ablation.The patient was in af with an ejection fraction of 30% at the start of the procedure.One hour into the procedure and after 16 successful ablations the patient converted to sinus rhythm with a bradycardic rate of 30 bpm.The patient's blood pressure was depressed, and patient was managed medically by the anesthesiologist.An echo was performed that showed minimal contraction of the whole heart.Patient went into ventricular tachycardia and ventricular fibrillation (vt/vf) multiple times, but the vt/vf event was self-terminated.A balloon pump was placed and then replaced with an impella heart device while the patient was intubated.On (b)(6) 2018 the impella device was removed.An echocardiogram on (b)(6) 2018 showed no pericardial effusion and an ejection fraction of 30%.(question for me only: ef unchanged from the start of the procedure?) on (b)(6) 2018 patient was extubated, is out of icu and recovering.There was no report of any atricure device malfunction.This was a procedural complication.

• 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 ; 5137554563
• MDR Report Key: 8170246
• MDR Text Key: 130525775
• Report Number: 3011706110-2018-00222
• 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: Physician
• Type of Report: Initial
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2018
• 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): Life Threatening; Required Intervention