• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ATRICURE, INC. WOLF LUMITIP DISSECTOR Back to Search Results
Model Number WOLF LUMITIP DISSECTOR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation of Vessels (2135)
Event Date 06/23/2017
Event Type  Injury  
Manufacturer Narrative
Case-(b)(4). The device was not returned for evaluation; however, the device history review was completed. There is nothing in the device history review to indicate the devices were released with any non-conformances that would have contributed to the complaint.
 
Event Description
On (b)(6)2017 a male patient had a tt maze procedure. The surgeon was going around the pulmonary vein with a mid1 and torqued the device. He was about to pull the tape from around the pulmonary vein when a bleed was noted and the decision was made for the case to be converted to a sternotomy with the patient on bypass. This did add additional time for the time it took to convert the case. The dissection on the pulmonary vein was repaired with suturing and the loss of blood and drop in blood pressure did warrant a transfusion of an unknown amount. The ablation was completed as planned only via open-chest. An emr2 and the cryo3 were both used as concomitant products. Upon completion of the case, patient was doing fine and 5 days¿ post procedure, the surgeon stated that the patient was still recovering fine. No device malfunction was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameWOLF LUMITIP DISSECTOR
Type of DeviceWOLF 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 Key6728275
MDR Text Key80549582
Report Number3011706110-2017-00063
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111020
Number of Events Reported1
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 07/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other Health Care Professional
Device Expiration Date03/01/2020
Device Model NumberWOLF LUMITIP DISSECTOR
Device Catalogue NumberA000195
Device Lot Number72256
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 Received06/23/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/15/2017
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: 07/20/2017 Patient Sequence Number: 1
Treatment
EMR2, CRYO3
-
-