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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 Great Vessel Perforation (2152)
Event Date 04/09/2021
Event Type  Injury  
Manufacturer Narrative
Case- (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 device was not reported or able to be subsequently ascertained.
 
Event Description
It was reported on (b)(6) 2021 that a (b)(6) male patient underwent a totally thoracoscopic (tt) ablation and left atrial appendage (laa) management procedure. During the articulation of the mid1 dissector, venous blood was noticed. The procedure was converted to a sternotomy. The physician lifted the heart to look for the location of bleeding, and bleeding was observed from the inferior vena cava (ivc) and sutured. The ablation was completed and a achv45 was placed on the laa. Patient was stable post procedure. 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 Key11740192
MDR Text Key250262490
Report Number3011706110-2021-00019
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 04/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMID1
Device Catalogue NumberA000195
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 Received04/09/2021
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: 04/28/2021 Patient Sequence Number: 1
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