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 Problem Pleural Effusion (2010)

Event Date 06/07/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was discarded by the facility but a device history review was obtained.A dhr has been obtained for lot number 76539.There is nothing in the device history record that would indicate that the devices were released with any non-conformances that would contribute to the complaint.

Event Description

On (b)(6) 2018 a (b)(6) female patient in the converge study underwent an off-pump convergent procedure via subxiphoid access.On (b)(6) 2018 patient developed symptoms of shortness of breath and bloating.On (b)(6) 2018 a cxr revealed trace bilateral pleural effusions with bibasilar atelectasis.Lasix iv bid doses were increased until (b)(6) 2018.The patient was symptomatic with increased shortness of breath.A collection of pleural fluid was identified in the right lung base via us.A thoracentesis removed 475 ml of fluid.Patient stated relief of sob after fluid was removed.On (b)(6) 2018, patient was discharged with improved symptoms.It was stated that this event was related to the procedure per information given from clinical research.

• 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 ; 7555 innovation way; mason, OH 45040
• MDR Report Key: 7656823
• MDR Text Key: 112994720
• Report Number: 3011706110-2018-00184
• 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: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• 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: 06/18/2018
• 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
• Patient Age: 72 YR
• Patient Weight: 87