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U.S. Department of Health and Human Services

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

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ATRICURE, INC. WOLF LUMITIP DISSECTOR Back to Search Results
Model Number WOLF LUMITIP DISSECTOR
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)
Patient Problem Atrial Perforation (2511)
Event Date 05/25/2017
Event Type  Injury  
Manufacturer Narrative
(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
During a minimally invasive surgery total thoracic maze / laa procedure, the surgeon was going around the right pulmonary vein with a mid1. Surgeon said he was "overzealous" with going around the backside of the atrium and punctured the atrium. The surgeon did state that the patient had 3 atriums, something very uncommon. The mid1 was kept in place while the case was converted to a sternotomy and patient was placed on pump. Doctor had to put some sutures in the hole in the atrium and the case continued as planned. The maze was continued and the clip was placed as planned. The delay in case was the time it took to put patient on pump, approx. 20 minutes, patient outcome was good. "minimal" blood loss since mid1 was kept in place until patient was converted and surgeon could suture the hole.
 
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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 Key6655594
MDR Text Key78020092
Report Number3011706110-2017-00055
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
Type of Report Initial
Report Date 06/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date01/01/2020
Device Model NumberWOLF LUMITIP DISSECTOR
Device Catalogue NumberA000195
Device Lot Number71450
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/25/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/02/2017
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: 06/20/2017 Patient Sequence Number: 1
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