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 Unspecified Infection (1930); Heart Failure (2206)

Event Date 09/25/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).There was no device malfunction reported, device functioned as expected.The device was not returned for evaluation and no device history review was done as no lot number was provided.

Event Description

A patient had a convergent procedure on (b)(6) 2017 and was enrolled in the converge trial.On (b)(6) 2017, she presented to the er with worsening bilateral edema/weeping and pain for 2 days.The patient confirmed worsening sob over shorter distances but her bad knees restricted her mobility as well and her family reported that her "breathing sounds wet" over the last two days.A ct scan showed pleural effusion, pericardial effusion (but not >1cm and not consistent with tamponade physiology), and pericarditis.Repeat transthoracic echocardiogram performed on (b)(6) 2017 showed no tamponade but elevated rap, and a septal shudder with suspected some effusive constrictive physiology, about the same as (b)(6) 2017.On (b)(6) 2017 cardiology was consulted and the following diagnosis included acute pericarditis secondary to epicardial and endocardial ablation procedure, clinically associated heart failure most consistent with effusive constrictive pericarditis with peripheral edema presumably related to diastolic heart failure with some dyspnea, along with small pericardial effusion with probable fibrinous exudate, and left and right pleural effusion.The subjects conditions improved and on (b)(6) 2017 was discharged home.

• 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: 6965830
• MDR Text Key: 89925357
• Report Number: 3011706110-2017-00091
• 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: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 110