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U.S. Department of Health and Human Services

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

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B. BRAUN MEDICAL SAS VENATECH FILTER Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Great Vessel Perforation (2152)
Event Date 07/11/2018
Event Type  Injury  
Event Description

Filter was implanted into patient on or about (b)(6) 2015. On (b)(6) 2018, patient underwent a computerized tomography scan ("ct scan") of the abdomen. Examination of the ct scan by a qualified expert radiologist revealed that the ivc filter is malpositioned with struts perforating through the wall of the ivc.

 
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Type of DeviceVENATECH FILTER
Manufacturer (Section D)
B. BRAUN MEDICAL SAS
26 rue armengaud
saint-cloud, 92210
FR 92210
MDR Report Key12246425
MDR Text Key264095954
Report Number3006332832-2021-00005
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 07/29/2021,07/28/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/29/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Was Device Available For Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/29/2021
Distributor Facility Aware Date07/15/2021
Event Location No Information
Date Report TO Manufacturer07/23/2021
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: 07/29/2021 Patient Sequence Number: 1
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