BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENATECH LP

    MDR report key: 6944532 · Received October 12, 2017

    Report

    Report Number
    9612452-2017-00045
    Event Type
    Injury
    Date Received
    October 12, 2017
    Report Date
    October 10, 2017
    Manufacturer
    B.BRAUN MEDICAL SAS
    Product Code
    DTK
    UDI-DI
    04038653918164
    PMA / PMN Number
    K010485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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. 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

    ON OR ABOUT (B)(6) 2010, PATIENT WAS IMPLANTED WITH THE LP FILTER. PATIENT HAD BEEN HOSPITALIZED FOR THE PREVENTION OF PULMONARY EMBOLISM. IT WAS DECIDED THAT THE PATIENT WOULD UNDERGO AN IMPLANT OF A FILTER TO PREVENT FURTHER ISSUES WITH BLOOD CLOTS. PHYSICIAN DEPLOYED THE FILTER THROUGH THE RIGHT JUGULAR IN ACCORDANCE WITH BRAUN'S SPECIFIC INSTRUCTIONS, GUIDELINES, AND DIRECTIVES. ON OR ABOUT SOMETIME IN THE (B)(6) OF 2016, PATIENT HAD A SCAN DONE AT (B)(6) HOSPITAL. DURING THAT TIME, PATIENT WAS INFORMED OF A PULMONARY EMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724913 VENATECH LP VENA CAVA FILTER SYSTEM DTK B.BRAUN MEDICAL SAS 31335 J056036V 04038653918164

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening