BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENALI FEMORAL SYSTEM

    MDR report key: 3961116 · Received May 27, 2014

    Report

    Report Number
    2020394-2014-00237
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 8, 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
    AR, 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 MANUFACTURING RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS LOT NUMBER AND FAILURE MODE. THE DEVICE WAS NOT RETURNED. IMAGES WERE NOT PROVIDED. THE COMPLAINT INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEPLOYMENT OF A VENA CAVA FILTER, SOME FILTER LIMITS REMAINED INSIDE THE DELIVERY SHEATH. ADD'L MANIPULATION WAS USED TO COMPLETE THE FILTER DEPLOYMENT; HOWEVER, THE FILTER TILTED. A SNARE DEVICE WAS USED TO RETRIEVE THE FILTER. A NEW FILTER WAS DEPLOYED SUCCESSFULLY. THERE WAS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311951 DENALI FEMORAL SYSTEM DTK BARD PERIPHERAL VASCULAR, INC. GFXK3041

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention