BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREATBATCH MEDICAL STEERABLE SHEATH

    MDR report key: 6649691 · Received June 19, 2017

    Report

    Report Number
    2183787-2017-00072
    Event Type
    Injury
    Date Received
    June 19, 2017
    Date of Event
    March 14, 2017
    Report Date
    June 7, 2017
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K061119
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    AS REPORTED: VASCULAR ACCESS COMPLICATION: FEMORAL ARTERY PSEUDOANEURYSM: ADMITTED TO HOSPITAL WITH RIGHT GROIN PAIN, FOUND TO HAVE FEMORAL HAEMATOMA AND SMALL PSEUDOANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430381 GREATBATCH MEDICAL STEERABLE SHEATH INTRODUCER, CATHETER DYB GREATBATCH MEDICAL 10876-002 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention