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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL SAS LP VENATECH FILTER

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B. BRAUN MEDICAL SAS LP VENATECH FILTER Back to Search Results
Model Number 31335
Device Problem Insufficient Information (3190)
Patient Problem Great Vessel Perforation (2152)
Event Date 01/08/2019
Event Type  Injury  
Event Description

Filter was implanted into patient on or about (b)(6) 2011. On (b)(6) 2017, patient underwent a computerized tomography scan ("ct scan") of the abdomen and pelvis. On (b)(6) 2019, a review of the (b)(6) 2017, ct scan was performed, revealing the filter was in fact tilted, with multiple struts perforating the ivc.

 
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Brand NameLP VENATECH FILTER
Type of DeviceVENATECH FILTER
Manufacturer (Section D)
B. BRAUN MEDICAL SAS
26 rue armengaud
saint-cloud, 92210
FR 92210
MDR Report Key12301718
MDR Text Key265836967
Report Number3006332832-2021-00009
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial
Report Date 08/10/2021,08/09/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/10/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number31335
Device Catalogue Number5010024
Device LOT NumberJ342994V
Was Device Available For Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/10/2021
Distributor Facility Aware Date07/19/2021
Event Location No Information
Date Report TO Manufacturer08/05/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/10/2021 Patient Sequence Number: 1
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