BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENATECH LP

    MDR report key: 9604855 · Received January 19, 2020

    Report

    Report Number
    9612452-2020-00003
    Event Type
    Injury
    Date Received
    January 19, 2020
    Date of Event
    December 4, 2019
    Report Date
    January 17, 2020
    Manufacturer
    B.BRAUN MEDICAL SAS
    Product Code
    DTK
    UDI-DI
    04038653918164
    PMA / PMN Number
    K010485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 CONCLUSION CAN BE DRAWN. THIS TYPE OF INCIDENT IS KNOWN COMPLICATION OF THE VENA CAVA FILTER. COMPARED TO THE LITERATURE, THE COMPLAINT RATE FOR THIS TYPE OF INCIDENT WITH VENATECH LP IS LOW AND SATISFACTORY. THE BENEFITS OVERWEIGHT THE RISKS. NO CORRECTIVE ACTION IS CURRENTLY 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.

    Description of Event or Problem · 1

    INITIAL ATTEMPT AT PLACING A VENATECH LP FILTER WAS COMPLICATED BY THE FILTER NOT OPENING UP AND DEPLOYING PROPERLY. THIS RESULTED IN FILTER MIGRATION INTO THE RIGHT VENTRICLE AND ULTIMATELY INTO THE RIGHT LOWER LOBE PULMONARY ARTERY. THE FILTER NEVER PROPERLY DEPLOYED. ULTIMATELY, A DECISION WAS MADE TO LEAVE THE FILTER AS AN INTENTIONAL FOREIGN BODY, AS THE RISK OF ATTEMPTING TO RETRIEVE IT OUTWEIGHED THE BENEFIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68028 VENATECH LP VENA CAVA FILTER DTK B.BRAUN MEDICAL SAS 31335 36943446 04038653918164

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention