BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENALI JUGULAR SYSTEM

    MDR report key: 3842703 · Received February 21, 2014

    Report

    Report Number
    2020394-2014-00053
    Event Type
    Injury
    Date Received
    February 21, 2014
    Date of Event
    February 1, 2014
    Report Date
    February 4, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K130366
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    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. IMAGES WERE NOT PROVIDED. THE COMPLAINT INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED EVENT. BASED ON THE AVAILABLE INFO, THE DEFINITIVE ROOT CAUSE IS UNK. IT IS UNK IF PT AND/OR PROCEDURAL FACTORS CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON DEPLOYMENT OF A VENA CAVA FILTER, THE FILTER LEGS WERE CROSSED AND DID NOT FULLY EXPAND. AN ATTEMPT WAS MADE TO OPEN THE FILTER LEGS WITH A CATHETER, BUT IT WAS UNSUCCESSFUL. THE FILTER WAS RETRIEVED WITH A SNARE DEVICE AND ANOTHER FILTER WAS DEPLOYED WITHOUT INCIDENT. THERE WAS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109181 DENALI JUGULAR SYSTEM DTK BARD PERIPHERAL VASCULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention