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

Model Number WOLF LUMITIP DISSECTOR

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problem Atrial Perforation (2511)

Event Date 05/25/2017

Event Type  Injury  

Manufacturer Narrative

(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

During a minimally invasive surgery total thoracic maze / laa procedure, the surgeon was going around the right pulmonary vein with a mid1. Surgeon said he was "overzealous" with going around the backside of the atrium and punctured the atrium. The surgeon did state that the patient had 3 atriums, something very uncommon. The mid1 was kept in place while the case was converted to a sternotomy and patient was placed on pump. Doctor had to put some sutures in the hole in the atrium and the case continued as planned. The maze was continued and the clip was placed as planned. The delay in case was the time it took to put patient on pump, approx. 20 minutes, patient outcome was good. "minimal" blood loss since mid1 was kept in place until patient was converted and surgeon could suture the hole.

• 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: 6655594
• Report Number: 3011706110-2017-00055
• 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

• Type of Report: Initial
• Report Date: 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 01/01/2020
• Device Model Number: WOLF LUMITIP DISSECTOR
• Device Catalogue Number: A000195
• Device Lot Number: 71450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Outcome(s): Life Threatening; Required Intervention