BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS GLIDELIGHT LASER SHEATH

    MDR report key: 5679150 · Received May 25, 2016

    Report

    Report Number
    1721279-2016-00069
    Event Type
    Death
    Date Received
    May 25, 2016
    Date of Event
    April 22, 2016
    Report Date
    May 4, 2016
    Manufacturer
    SPECTRANETICS
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A PROCEDURE TO EXTRACT 3 CARDIAC LEADS DUE TO A SYSTEMIC INFECTION. THE FIRST LEAD WAS EXTRACTED USING A 16FR GLIDELIGHT LASER SHEATH. AFTER EXTRACTION OF THE FIRST RV LEAD, A DROP IN THE PATIENT'S BLOOD PRESSURE WAS NOTED. THE CARDIAC SURGEON IMMEDIATELY CAME IN TO INTERVENE. AN SVC TEAR WAS IDENTIFIED. THE PATIENT EXPIRED DURING THE PROCEDURE. THIS REPORT IS BEING MADE AGAINST THE GLIDELIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334059 SPECTRANETICS GLIDELIGHT LASER SHEATH GLIDELIGHT MFA SPECTRANETICS 500-302 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death CARDIAC LEAD, MDT 6949 (IMPL. UNKNOWN)