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

Model Number EPI-SENSE

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

Patient Problem Hernia (2240)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned to atricure for evaluation as there was no indication of a device defect or malfunction.The device was discarded by the facility, lot number was unable to be ascertained.Device dicarded by facility.

Event Description

It was reported at a eacts conference in europe that a doctor in paris had a patient that had a post-operative trans-diaphragmatic hernia.

• 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: 6341541
• MDR Text Key: 67802384
• Report Number: 3003502395-2016-00167
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: EPI-SENSE
• Device Catalogue Number: CDK-1413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Outcome(s): Life Threatening; Required Intervention