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

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.

• 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 Key: 4431740
• MDR Text Key: 5391531
• Report Number: 3006332832-2015-00003
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Date: 04/30/2019
• Device Model Number: 31335
• Device Catalogue Number: 5010024
• Device Lot Number: N127037V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/15/2015
• Distributor Facility Aware Date: 12/03/2014
• Event Location: Hospital
• Date Report to Manufacturer: 01/15/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/15/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COOK FILTER RETRIEVAL SET; OPTION FILTER
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR