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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 5010024
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Date 03/09/2017
Event Type  Injury  
Manufacturer Narrative
Batch history review: we have checked the manufacturing file of the involved batch which complies with our specifications and does not present any discrepancy. No other similar complaint has been reported to us on this batch of vena cava filters released in october 2004. Investigation results we did not receive the x-ray pictures or detailed information for investigation. No information is given to explain why the filter was retrieve whereas the venatech lp filter is a permanent filter and is not retrievable. Conclusion: without concrete element, no thorough investigation can be performed. A causality link between the device and the reported event cannot be established. No conclusion can be drawn about the event root cause. If new elements become available in the future, we will update the case.
 
Event Description
"filter was implanted in patient on or about (b)(6) 2005 at (b)(6). On (b)(6) 2017, patient underwent iliocaval recanalization with stenting and a complex filter retrieval at (b)(6). ".
 
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Brand NameVENATECH LP
Type of DeviceVENA CAVA FILTER
Manufacturer (Section D)
B.BRAUN MEDICAL SAS
26 rue armengaud
saint cloud, 92210
FR 92210
Manufacturer (Section G)
B.BRAUN MEDICAL SAS FRANCE
30 avenue des temps modernes
chasseneuil du poitou 86360
FR 86360
Manufacturer Contact
catherine boismenu
30 avenue des temps modernes
chasseneuil du poitou, 86360
FR   86360
MDR Report Key12239127
MDR Text Key263854659
Report Number9612452-2021-00033
Device Sequence Number1
Product Code DTK
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K010485
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 07/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/11/2009
Device Model Number5010024
Device Catalogue Number5010024
Device Lot NumberF0624410
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/12/2004
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 07/28/2021 Patient Sequence Number: 1
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