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U.S. Department of Health and Human Services

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

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B. BRAUN MEDICAL SAS VENATECH LP VENA CAVA FILTER Back to Search Results
Model Number 31335
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Information (3190)
Event Date 12/02/2014
Event Type  Injury  
Event Description
Pt had the option filter in place, referring physician requested that it be removed and a permanent filter placed.The access site was right internal jugular.An amplatz 0.035 wire was used.Option was removed using cook filter retrieval set.Physician used same guidewire, ignoring braun ifu.Cook filter retrieval introducer was used instead of the venatech introducer.Physician was informed that cook retrieval introducer was 11f and there were concerns about downsizing of 9f system.Venatech filter appeared not to open.B.Braun multi-snare 5 mm used to retrieve the snare catheter.Filter was captured and pulled upward into the jugular vein.Surgeon performed cut down to remove the filter which he had sutured closed.
 
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Brand Name
VENATECH LP VENA CAVA FILTER
Type of Device
VENA CAVA FILTER
Manufacturer (Section D)
B. BRAUN MEDICAL SAS
chasseneuil, cedex vienne
FR 
Manufacturer (Section G)
B. BRAUN INTERVENTIONAL SYSTEMS
14276 23rd. avenue north
plymouth MN 55447
Manufacturer Contact
14276 23rd. avenue north
plymouth, MN 55447
MDR Report Key4431740
MDR Text Key5391531
Report Number3006332832-2015-00003
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Source Type Unknown
Reporter Occupation Other
Type of Report Initial
Report Date 01/15/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2019
Device Model Number31335
Device Catalogue Number5010024
Device Lot NumberN127037V
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/15/2015
Distributor Facility Aware Date12/03/2014
Event Location Hospital
Date Report to Manufacturer01/15/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/15/2015
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
COOK FILTER RETRIEVAL SET; OPTION FILTER
Patient Outcome(s) Required Intervention;
Patient Age63 YR
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