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U.S. Department of Health and Human Services

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

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B. BRAUN MEDICAL SAS CONVERTIBLE VENATECH FILTER Back to Search Results
Catalog Number 5010028
Device Problems Improper or Incorrect Procedure or Method (2017); Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/20/2020
Event Type  Injury  
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 NameCONVERTIBLE VENATECH FILTER
Type of DeviceVENATECH FILTER
Manufacturer (Section D)
B. BRAUN MEDICAL SAS
26 rue armengaud
saint-cloud 92210
FR 92210
MDR Report Key10787042
MDR Text Key214651704
Report Number3006332832-2020-00007
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 Distributor
Reporter Occupation
Type of Report Initial
Report Date 11/04/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/04/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5010028
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/04/2020
Distributor Facility Aware Date10/20/2020
Event Location Hospital
Date Report TO Manufacturer10/26/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 11/04/2020 Patient Sequence Number: 1
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