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 Hernia (2240)

Event Date 12/08/2016

Event Type  Injury  

Manufacturer Narrative

Case-(b)(4).The device was not returned for evaluation but a device history review was obtained for lot number af271401.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

It was reported on (b)(6) 2016, that a (b)(6) -year-old male patient had an off-pump convergent study procedure with successful conversion to sinus rhythm.On (b)(6) 2016, the patient presented to ep with an incisional hernia noted under the healed sub-xiphoid incision.Patient states it developed after heavy lifting and hernia swelling resolves when he lies flat.He denies pain, nausea, and obstructive symptoms.The surgeon evaluated the patient and referred to a general surgeon for repair.Patient had a successful incisional hernia repair with mesh implant on (b)(6) 2017.This event has previously been reported to the agency under ide study # (b)(4).This event has been adjudicated as a procedural issue as part of the ide study # (b)(4).Although this event has not been attributed to the device, atricure is reporting this event under part 806.

• 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 ; 5137554563
• MDR Report Key: 7790832
• MDR Text Key: 117421158
• Report Number: 3011706110-2018-00202
• 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: 08/16/2018

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 Expiration Date: 12/31/2016
• Device Model Number: CDK-1413
• Device Catalogue Number: CDK-1413
• Device Lot Number: AF271404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2016
• Initial Date FDA Received: 08/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 136