MAUDE Adverse Event Report: ATRICURE, INC. WOLF LUMITIP DISSECTOR

Model Number MID1

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

Patient Problem Cardiac Perforation (2513)

Event Date 11/27/2018

Event Type  Injury  

Manufacturer Narrative

Case-(b)(4).The atricure mid1 device lot number 84689 was returned and was functionally evaluated.The device passed all inspection criteria and the functional check.The event was confirmed as a procedural complication.

Event Description

It was reported that on (b)(6) 2018 a female patient underwent a tt surgical ablation.During the case the surgeon was attempting to go around the right pulmonary veins using the mid1 dissector.When the surgeon was about halfway around the pulmonary veins and beginning to see the light from the dissector, blood flooded in the pericardium.It was suspected that the surgeon had created a hole in the posterior left atrium.The surgeon converted the procedure to a full sternotomy, the patient was placed on-pump, the atrial tear was sutured, and the maze ablation procedure was completed.During post-op discussion of the surgical procedure, the surgeon stated that the patient had a very thin tissue in the posterior left atrium and that the patient may have had an extra pericardial reflection or fold in the tissue.Patient did receive a transfusion and is doing well.There was no report of any atricure device malfunction.This was a procedural complication.

• Brand Name: WOLF LUMITIP DISSECTOR
• Type of Device: WOLF LUMITIP DISSECTOR
• 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: 8170262
• MDR Text Key: 130533782
• Report Number: 3011706110-2018-00223
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111020
• 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: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2021
• Device Model Number: MID1
• Device Catalogue Number: A000195
• Device Lot Number: 84689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2018
• 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