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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL SAS VENATECH - LGM 30D/U VENA CAVA FILTER SYSTEM

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B. BRAUN MEDICAL SAS VENATECH - LGM 30D/U VENA CAVA FILTER SYSTEM Back to Search Results
Catalog Number 5010519
Device Problems Filter; Difficult to insert
Event Date 03/04/2007
Event Type  Injury  
Event Description

A vena tech lgm vena cava filter was inadvertently placed upside down in an infrarenal position. The filter migrated to the patient's heart, and was surgically explanted. Importer narrative: based on information provided by the manufacturer this event is likely a result of physician error. The manufacturer utilizes quality control steps and specialized loading equipment that make it impossible for the filter to be loaded upside down during production. As a result, in order to place the filter upside down, user error is a certainty.

 
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Brand NameVENATECH - LGM 30D/U VENA CAVA FILTER SYSTEM
Type of DeviceVENA CAVA FILTER
Manufacturer (Section D)
B. BRAUN MEDICAL SAS
chasseneuil, cedex *
FRANCE *
MDR Report Key893086
Report Number3006332832-2007-00001
Device Sequence Number1
Product CodeDTK
Report Source Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 04/11/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/24/2007
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date08/01/2011
Device Catalogue Number5010519
Device LOT NumberF0831760
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/11/2007
Distributor Facility Aware Date03/13/2007
Device Age7 mo
Event Location Hospital
Date Report TO Manufacturer04/11/2007
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 07/24/2007 Patient Sequence Number: 1
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