• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

B.BRAUN MEDICAL SAS VENATECH LP VENA CAVE FILTER SYSTEM Back to Search Results
Device Problem Use of Device Problem (1670)
Patient Problem Calcium Deposits/Calcification (1758)
Event Date 07/19/2017
Event Type  Injury  
Manufacturer Narrative

Batch history review is not possible because either the product reference nor the batch number of the involved device is known. Despite requests, either precise information about the device nor x-ray pictures are available for analysis. Consequently no thorough investigation can be performed. No link between the filter and the reported complaint can be established. No conclusion can be drawn. B braun medical (b)(4) has provided all the information currently available. In spite of all reasonable efforts being made to obtain further information, at this time we have not met with success.

 
Event Description

"on or about on (b)(6) 2003, patient was implanted with the venatech vena cava filter. Patient had been hospitalized, and upon information and belief, was implanted the filter for pre-surgical purposes of prevent further dvts. The filter system that was implanted was positively identified on patient's medical records. The surgery was ordered by a dr. (b)(6). Upon information and belief, the filter was implanted and utilized in accordance with braun's specific instructions, guidelines, and directives. The patient has never considered for revision or removal of the device by any medical professionals, nor was the patient recommended to consider removal upon discharge. On or about (b)(6) 2017, patient received a scan on abdomen region after complaints of lower extremity swelling. The scan confirmed patient's ivc filter was within the affect region and mild calcification within that area as well. The patient's implant, remains within the body for over fourteen years, which constitutes a long-term implant and made the patient dramatically more susceptible to the threat of imminent threat of death, migration, thrombosis, blockage or other life-threatening side effects. ".

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVENATECH LP
Type of DeviceVENA CAVE FILTER SYSTEM
Manufacturer (Section D)
B.BRAUN MEDICAL SAS
204 avenue du marechal juin
boulogne, 92100
FR 92100
Manufacturer (Section G)
B.BRAUN MEDICAL SAS
avenue des temps modernes
chasseneuil, 86361
FR 86361
Manufacturer Contact
catherine boismenu
30, avenue des temps modernes
chasseneuil du poitou 86360
FR   86360
MDR Report Key7057671
MDR Text Key92858077
Report Number9612452-2017-00046
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 Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial
Report Date 11/22/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/24/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/02/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 11/24/2017 Patient Sequence Number: 1
-
-