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 Pleural Effusion (2010); Renal Failure (2041); Pericardial Effusion (3271)

Event Date 02/20/2020

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 cdk-1413 was not reported or able to be subsequently ascertained.

Event Description

It was reported that on (b)(6) 2020 a patient underwent a convergent procedure on (b)(6) 2020 and was discharged on (b)(6) 2020.There was no reported device malfunction or procedural complications.On (b)(6) 2020 the patient presented to a different facility with chest pain and was hospitalized, the patient was diagnosed with renal failure, pericarditis and pleural effusion.An echocardiogram showed a moderate circumferential pleural effusion and pericardial effusion with borderline tamponade.It was reported that 600 cc of pericardial fluid was drained from patient¿s pericardium.Patient had a repeat echocardiogram which showed resolution of effusions, patient felt better and was discharged home in sinus rhythm.There was no reported device malfunction and no reported intra-operative 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 ; 5136448220
• MDR Report Key: 9891357
• MDR Text Key: 189327989
• Report Number: 3011706110-2020-00015
• 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: 03/27/2020

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2020
• Initial Date FDA Received: 03/27/2020
• 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): Life Threatening