BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENALI FEMORAL SYSTEM

    MDR report key: 3963860 · Received May 21, 2014

    Report

    Report Number
    2020394-2014-00226
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Report Date
    May 1, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K130366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE DEVICE WAS NOT RETURNED. ONE IMAGE WAS PROVIDED. BASED UPON THE IMAGE REVIEW, THE COMPLAINT INVESTIGATION IS INCONCLUSIVE FOR FILTER TILT; HOWEVER, IT IS CONFIRMED FOR CROSSED FILTER LEGS. THE INVESTIGATION IS INCONCLUSIVE FOR DEPLOYMENT ISSUES. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. IT IS UNKNOWN IF PATIENT AND/OR PROCEDURAL FACTORS CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEPLOYMENT OF A VENA CAVA FILTER, THE LAST TWO FILTER LEGS BECAME STUCK IN THE DELIVERY SHEATH. THE FILTER DEPLOYMENT WAS COMPLETED WITH ADDITIONAL MANIPULATION OF THE DELIVERY SYSTEM; HOWEVER, THE FILTER LEGS BECAME CROSSED AND THE FILTER TILTED. THE FILTER REMAINS IMPLANTED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301179 DENALI FEMORAL SYSTEM DTK BARD PERIPHERAL VASCULAR, INC. GFXE3384

    Patients

    Seq Age Sex Outcome Treatment
    1