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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 04/03/2017
Event Type  Injury  
Event Description

Filter was implanted into patient on (b)(6) 2004. On (b)(6) 2015, patient underwent a ct scan of the abdomen and pelvis. At that time the radiologist reading the images reported the presence of an ivc filter but gave no further description. The ct scan images were reviewed by another radiologist on (b)(6) 2017 and the first time it was noted that the vena tech ivc filter had perforated through the vena cava wall. More specifically, the radiologist found: the left anterolateral and right posterolateral struts have penetrated through the ivc wall.

 
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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 Key12266767
MDR Text Key264726076
Report Number3006332832-2021-00008
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 08/03/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/03/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL Number31335
Device Catalogue Number5010024
Device LOT NumberF0535260
Was Device Available For Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/03/2021
Distributor Facility Aware Date07/19/2021
Event Location No Information
Date Report TO Manufacturer08/02/2021
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: 08/03/2021 Patient Sequence Number: 1
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