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 Problem Perforation (2001)

Event Date 06/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4) there were no device malfunction reported, all devices functioned as expected.The device was not returned for evaluation and no device history review was done as no lot number was provided.

Event Description

A (b)(6) male underwent deep style vats maze procedure was heparinized, and off pump at the start of procedure.The surgeon had a mid1 around the pv and could see the light from the mid1, while attempting to outage the dial to articulate the mid1, he lost sight of the light and then observed blood.Surgeon made an immediate call to convert to a sternotomy.The bleed was from the posterior la that was corrected with suturing.There was an unknown amount of blood loss but not enough to necessitate a transfusion.There was approximately an hour added to the case.The doctor attributes the bleed to thin, delicate tissue giving rise to push through during dissection.

• 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: 6689394
• MDR Text Key: 79151298
• Report Number: 3011706110-2017-00059
• 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
• Type of Report: Initial
• Report Date: 07/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: WOLF LUMITIP DISSECTOR
• Device Catalogue Number: A000195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2017
• 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 Sequence Number: 1
• Treatment: MAX5,EML2,EMR2,CRYO2
• Patient Outcome(s): Life Threatening; Required Intervention; Disability
• Patient Age: 64 YR