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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 SYSTEM

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B.BRAUN MEDICAL SAS VENATECH LP VENA CAVA FILTER SYSTEM Back to Search Results
Model Number 5010024
Device Problem Use of Device Problem (1670)
Patient Problem Pain (1994)
Event Date 12/07/2015
Event Type  Injury  
Manufacturer Narrative

Batch history review: the manufacturing file was reviewed. It is compliant with our specifications and no abnormality was detected. No other similar complaint was reported on this batch of vena cava filters. Investigation despite requests, either precise information about the incident 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 (b)(6) 2007, patient was implanted with the lp filter system. Patient had been hospitalized for problems and had the ivc filter implanted for the treatment of recurrent pulmonary embolisms. It was decided that the patient would undergo the implant to prevent further complications. Based on advice given the patient agreed to the implantation of the ivc filter. The physician conducted this procedure and deployed the filter in the patent's right groin at the l3-l4 level. The filter was positively identified on medical records and implant labels. 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. The patient, on or about (b)(6) 2015 was hospitalized for chronic right side pain in the area where the ivc filter was implanted. A scan on the patient confirmed that an ivc filter was present at the l3-l4. Chronic pains in the area where the filter was implanted can be an indicator of further complications with the filter such as migration, tilt, fracture or breakage of the filter, perforation of the vena cava or other soft tissue, and other serious problems. The patient's implant, remains within the body for over nine 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. ".

 
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Brand NameVENATECH LP
Type of DeviceVENA CAVA 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 Key7057667
MDR Text Key92864337
Report Number9612452-2017-00047
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK010485
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial
Report Date 11/24/2017
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
Device EXPIRATION Date01/31/2012
Device MODEL Number5010024
Device Catalogue Number5010024
Device LOT NumberF0101263V
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 Received11/06/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/06/2007
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
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