MAUDE Adverse Event Report: ATRICURE INC. 3CM GUIDED COAG DEVICE GEN 4; EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX

Catalog Number CDK-1413

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hernia (2240); Pericardial Effusion (3271)

Event Date 07/28/2016

Event Type  Injury  

Manufacturer Narrative

Complaint number (b)(4).The device was not returned to atricure for evaluation as there was no indication of a device defect or malfunction.No known malfunction, facility discared.

Event Description

The surgeon reported that one patient had returned after a convergent procedure with a pericardial effusion.The effusion was drained.The patient is in sinus rhythm.Per additional information that was received on 11/02/2016, patient is now presenting with incisional hernia requiring surgery to repair.

• Brand Name: 3CM GUIDED COAG DEVICE GEN 4
• Type of Device: EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX
• Manufacturer (Section D): ATRICURE INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: ranjana iyer ; 7555 innovation way; mason, OH 45040 ; 5137555328
• MDR Report Key: 6094753
• MDR Text Key: 59715909
• Report Number: 3003502395-2016-00157
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120857
• 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: 11/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CDK-1413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CANNULA
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 92