BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIDIAN FILTER SYSTEM- JUGULAR

    MDR report key: 2972005 · Received January 22, 2013

    Report

    Report Number
    2020394-2013-00015
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 28, 2012
    Report Date
    December 28, 2012
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K102511
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING REVIEW COULD NOT BE CONDUCTED AS THE INVESTIGATION LOT NUMBER IS UNKNOWN. THE DEVICE WAS NOT RETURNED. ONE DIGITAL PHOTO WAS PROVIDED. BASED ON THIS PHOTO REVIEW, THE INVESTIGATION IS CONFIRMED FOR A DETACHED FILTER LIMB. AS NO ADDITIONAL IMAGES WERE PROVIDED, THE INVESTIGATION IS INCONCLUSIVE FOR FILTER TILT AND REMOVAL DIFFICULTIES. BASED UPON THE REPORTED EVENT, THE FILTER WAS TILTED BEFORE REMOVAL. AS SUCH, THE USER EXPERIENCED DIFFICULTY REMOVING THE FILTER DUE TO THE TILT. HOWEVER, BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THE FILTER TILT AND FILER LIMB DETACHMENT IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SCHEDULED RETRIEVAL OF A VENA CAVA FILTER APPROXIMATELY ONE YEAR POST IMPLANTATION, THE FILTER WAS NOTED TO BE TILTED. DURING THE RETRIEVAL, A FILTER ARM DETACHED AND TRAVELED TO THE RIGHT PULMONARY ARTERY. THE FILTER WAS SUCCESSFULLY REMOVED AND THE DETACHED ARM REMAINS IN THE RIGHT LUNG. THE PATIENT WAS REPORTED TO BE ASYMPTOMATIC AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32173 MERIDIAN FILTER SYSTEM- JUGULAR DTK BARD PERIPHERAL VASCULAR, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR