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

Model Number WOLF LUMITIP DISSECTOR

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

Patient Problem Perforation of Vessels (2135)

Event Date 06/23/2017

Event Type  Injury  

Manufacturer Narrative

Case-(b)(4).The device was not returned for evaluation; however, the device history review was completed.There is nothing in the device history review to indicate the devices were released with any non-conformances that would have contributed to the complaint.

Event Description

On (b)(6)2017 a male patient had a tt maze procedure.The surgeon was going around the pulmonary vein with a mid1 and torqued the device.He was about to pull the tape from around the pulmonary vein when a bleed was noted and the decision was made for the case to be converted to a sternotomy with the patient on bypass.This did add additional time for the time it took to convert the case.The dissection on the pulmonary vein was repaired with suturing and the loss of blood and drop in blood pressure did warrant a transfusion of an unknown amount.The ablation was completed as planned only via open-chest.An emr2 and the cryo3 were both used as concomitant products.Upon completion of the case, patient was doing fine and 5 days¿ post procedure, the surgeon stated that the patient was still recovering fine.No device malfunction was reported.

• 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: anupam bedi
• MDR Report Key: 6728275
• MDR Text Key: 80549582
• Report Number: 3011706110-2017-00063
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Expiration Date: 03/01/2020
• Device Model Number: WOLF LUMITIP DISSECTOR
• Device Catalogue Number: A000195
• Device Lot Number: 72256
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/15/2017
• 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
• Treatment: EMR2, CRYO3
• Patient Outcome(s): Life Threatening; Required Intervention