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U.S. Department of Health and Human Services

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

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B.BRAUN MEDICAL SAS VENATECH CONVERTIBLE FILTER VENA CAVA FILTER SYSTEM Back to Search Results
Model Number 5010028
Device Problems Difficult to Fold, Unfold or Collapse (1254); Improper or Incorrect Procedure or Method (2017); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/20/2020
Event Type  Malfunction  
Manufacturer Narrative

Investigation: batch history review is not possible because neither batch number is unknown. The involved device is not available for investigation; the filter is still implanted in the patient's body. A x-rays picture was forwarded for analysis. It shows two distorted stabilizers but it does not allow us to determine the origin of the incorrect filter deployment. Conclusion: the elements received do not allow us to determine the root cause of this incident. There is no upward trend on similar incidents. No corrective action is envisaged. B braun medical sas 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

Upon placement, the filter did not open and one leg is extending outside the filter profile. Pre-placement cavogram is not available for review. The final film taken after implantation is available. The indication for filter implantation is unknown. The approach was jugular. The diameter of the vena cava before implantation is unknown. A second filter was not used to complete the procedure. Physician reports that the patient is very ill and the account does not expect any further intervention regarding this filter. There was no pressure felt or catching of the hooks in the distal portion of the sheath. Very flat ivc and the fellow deployed it probably by pushing it forward, so it caught on the wall.

 
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Brand NameVENATECH CONVERTIBLE FILTER
Type of DeviceVENA CAVA FILTER SYSTEM
Manufacturer (Section D)
B.BRAUN MEDICAL SAS
26 rue armengaud
saint cloud, 92210
FR 92210
Manufacturer (Section G)
B.BRAUN MEDICAL 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 Key10906179
MDR Text Key239587608
Report Number9612452-2020-00043
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK152765
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 11/24/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/25/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number5010028
Device Catalogue Number5010028
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2020
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? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/25/2020 Patient Sequence Number: 1
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