BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREATBATCH MEDICAL STEERABLE SHEATH

    MDR report key: 6557575 · Received May 10, 2017

    Report

    Report Number
    2183787-2017-00063
    Event Type
    Injury
    Date Received
    May 10, 2017
    Date of Event
    June 24, 2016
    Report Date
    April 26, 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

    AFTER AF ABLATION A FEMORAL ARTERY PSEUDOANEURYSM WAS OBSERVED ON THE RIGHT SIDE NEAR THE PUNCTURE POINT. THE PATIENT WAS INVOLVED IN A STUDY (THE STUDY DETAILS ARE UNKNOWN).THE PATIENT WAS TREATED WITH AN ULTRASOUND GUIDED THROMBIN INJECTION. THERE WAS NO ALLEGED PRODUCT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338758 GREATBATCH MEDICAL STEERABLE SHEATH INTRODUCER, CATHETER DYB GREATBATCH MEDICAL 10876-002 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention