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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 Thromboembolism (2654)
Event Date 01/19/2017
Event Type  Injury  
Event Description

Filter was implanted into patient on or about (b)(6) 2015. On (b)(6) 2017, patient underwent venous surgery. A venography was performed. The braun vena tech ivc filter was occluded. A catheter placement procedure was also performed in the ivc along with ivc angioplasty and stenting. On (b)(6) 2017, patient underwent a computed tomography scan (ct scan). Examination of the ct scan by a qualified expert radiologist revealed that the filter was pressed against the right lateral sidewall of the ivc by a stent.

 
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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 Key12301659
MDR Text Key265833675
Report Number3006332832-2021-00010
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? No
Device Operator NO INFORMATION
Device MODEL Number31335
Device Catalogue Number5010024
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 Manufacturer08/06/2021
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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