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 (2001)

Event Date 06/19/2020

Event Type  Injury  

Manufacturer Narrative

Case (b)(4): the mid1 lot number 99690 was received for evaluation.The device passed all visual and functional tests.

Event Description

It was reported on 15-jul-2020 that on (b)(6) 2020 an (b)(6) year-old male patient with a history of atrial fibrillation and mitral regurgitation, underwent a left pulmonary vein isolation (pvi) procedure with left atrial appendage management.During the procedure, surgeon made a pericardial incision, dissected soft tissue around pulmonary vein (pv) using mid1 and used emt1 device to ablate back of pulmonary vein.During that process surgeon noted that there was bleeding from the roof of the left inferior pulmonary vein.The patient was placed on bypass and the surgeon sutured the bleeding site.An atriclip pro150 was placed on left atrial appendage.The procedure was completed without any delay.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: 10369959
• MDR Text Key: 207897242
• Report Number: 3011706110-2020-00020
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2022
• Device Model Number: MID1
• Device Catalogue Number: A000195
• Device Lot Number: 99690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Date Manufacturer Received: 07/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2020
• 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
• Patient Age: 87