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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 MID1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation of Vessels (2135)
Event Date 07/27/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4) the device was not returned for evaluation and a device history review was unable to be completed as the relevant lot number for the mid1 wolf lumitip dissector device was not reported or able to be subsequently ascertained.
 
Event Description
It was reported that on (b)(6) 2020 a patient underwent a minimally invasive maze procedure with left atrial appendage management (laam). When the surgeon was dissecting around the right pulmonary veins with the mid1 dissector, they perforated the left pulmonary inferior vein. According to the surgeon, the contributing factors were that the patient had a small atrium and the left pulmonary veins were set deep. The procedure was then converted to an open sternotomy. The surgeon repaired the perforation with pledgeted suture, with the maze procedure then being successfully with cryof device and an ach2 clip placed on the laa. Post-procedure, the patient remained stable. There was no reported device malfunction, and the adverse event was the result of a procedural complication.
 
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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
john ehlert
7555 innovation way
mason, OH 45040
5136448220
MDR Report Key10441207
MDR Text Key203990002
Report Number3011706110-2020-00024
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 08/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMID1
Device Catalogue NumberA000195
Device Lot NumberUNKNOWN
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 Received07/27/2020
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 Treatment Data
Date Received: 08/24/2020 Patient Sequence Number: 1
Treatment
MCR1, EMR2, MAX5, ACH2 ATRICLIP
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