BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENALI JUGULAR SYSTEM

    MDR report key: 3961114 · Received May 27, 2014

    Report

    Report Number
    2020394-2014-00234
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 6, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, SUBASSEMBLIES, MFG PROCESS, AND QC TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MFG RELATED CAUSE FOR THIS EVENT. THE DEVICE WAS RETURNED AND THE FILTER MET ALL REQUIRED SPECS. NO CROSSED/OVERLAPPING LIMITS WERE IDENTIFIED. THE COMPLAINT INVESTIGATION IS INCONCLUSIVE FOR THE FILTER FAILING TO FULLY EXPAND AND CEPHALAD MIGRATION, AS IMAGES WERE PROVIDED. BASED UPON THE AVAILABLE INFO, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNK. IT IS UNK IF PT AND/OR PROCEDURAL FACTORS CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEPLOYMENT OF A VENA CAVA FILTER, THE FILTER DID NOT FULLY EXPAND AND STARTED TO MOVE IN A CEPHALAD DIRECTION. THE FILTER WAS RETRIEVED WITH A SNARE DEVICE AND A NEW VENA CAVA FILTER WAS DEPLOYED WITHOUT INCIDENT. THERE WAS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312078 DENALI JUGULAR SYSTEM DTK BARD PERIPHERAL VASCULAR, INC. GFXL2790

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention