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 Perforation of Vessels (2135)

Event Date 07/27/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4) the device was not returned for evaluation and a device history review was unable to be completed as the relevant lot number for the mid1 wolf lumitip dissector device was not reported or able to be subsequently ascertained.

Event Description

It was reported that on (b)(6) 2020 a patient underwent a minimally invasive maze procedure with left atrial appendage management (laam).When the surgeon was dissecting around the right pulmonary veins with the mid1 dissector, they perforated the left pulmonary inferior vein.According to the surgeon, the contributing factors were that the patient had a small atrium and the left pulmonary veins were set deep.The procedure was then converted to an open sternotomy.The surgeon repaired the perforation with pledgeted suture, with the maze procedure then being successfully with cryof device and an ach2 clip placed on the laa.Post-procedure, the patient remained stable.There was no reported device malfunction, and the adverse event was the result of 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 ; 5136448220
• MDR Report Key: 10441207
• MDR Text Key: 203990002
• Report Number: 3011706110-2020-00024
• 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: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MID1
• Device Catalogue Number: A000195
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2020
• 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 Sequence Number: 1
• Treatment: MCR1, EMR2, MAX5, ACH2 ATRICLIP
• Patient Outcome(s): Life Threatening; Required Intervention