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

Model Number MID1

Device Problem Difficult to Advance (2920)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/11/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 a patient underwent a concomitant inappropriate sinus tachycardia (ist) ablation procedure.While dissecting with the mid1 device, bleeding was observed while tissue was dissected off the mid1 light.Bleeding continued, so the physician converted the procedure with a sternotomy and placed the patient on by-pass.An 8mm injury to the roof of the left atrium was repaired and patient came off by-pass without issue and is doing well.This was a procedural complication with no reported device malfunction.

Manufacturer Narrative

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

• 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: 14311277
• MDR Text Key: 290951053
• Report Number: 3011706110-2022-00015
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• 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: 04/11/2022
• 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: EMR
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 21 YR
• Patient Sex: Female