BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS GLIDELIGHT LASER SHEATH

    MDR report key: 4182865 · Received October 17, 2014

    Report

    Report Number
    1721279-2014-00175
    Event Type
    Death
    Date Received
    October 17, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A LEAD EXTRACTION CASE PERFORMED IN THE HYBRID OR TO REMOVE THREE (3) LEADS DUE TO BACTEREMIA. THE PHYSICIAN USED A 16-FR. GLIDELIGHT TO REMOVE A SJM 6947 LEAD (120 MONTHS OLD) FROM THE RV. THERE WAS A COMPLICATION DUE TO SCREW NOT COMING BACK, WHICH CAUSED A TAMPONADE WHEN IT RELEASED FROM HEART. A CT SURGEON OPENED AND FIXED THE RV INJURY, BUT THE RETRO PERITONEAL BLEEDING SOURCE COULD NOT BE FOUND DUE TO FEMORAL ARTERIAL ACCESS OF PERFUSION CANNULA. PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661335 SPECTRANETICS GLIDELIGHT LASER SHEATH 16F GLIDELIGHT MFA SPECTRANETICS CORPORATION 500-303 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death SJM 0154 CARDIAC LEAD| CVX-300 EXCIMER LASER| SJM 6947 CARDIAC LEAD| SJM 4076 CARDIAC LEAD