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 Problems Injury (2348); Blood Loss (2597)

Event Date 08/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4): no device returned. Product history review could not be performed due to no serial and/or lot information reported. No product malfunction reported during the incident.

Event Description

On (b)(6) 2017, a patient received a deep style procedure using a wolf lumitip dissector (mid1) for dissection. While the surgeon was routing the mid1 behind the rpv in an attempt to dissect more tissue between the right pa and the right superior pulmonary vein, he was unable to see the light. At that time, bleeding occurred and the surgeon had to change his approach to a full sternotomy to handle the bleeding. It was determined that the bleed source was from the right superior pulmonary vein, at the junction of the left atrium. The blood loss did not necessitate a blood transfusion during the procedure. The source of the bleeding was closed via suture and the case was able to be completed. The non-atricure product was an endoscopic suction irrigator, to which the surgeon attributed to the bleed. Per the surgeon, the patient was discharged home with no known issues during the remainder of the hospital stay and an uncomplicated prognosis. No device malfunction was reported during the incident. This event is 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: anupam bedi
• MDR Report Key: 6849169
• MDR Text Key: 85150554
• Report Number: 3011706110-2017-00079
• 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: 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: WOLF LUMITIP DISSECTOR
• Device Catalogue Number: A000195
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/07/2017 Patient Sequence Number: 1

Treatment

COBRA FUSION, SYNERGY CLAMPS, ATRICLIP PRO2