BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS GLIDELIGHT LASER SHEATH

    MDR report key: 4092840 · Received September 16, 2014

    Report

    Report Number
    1721279-2014-00156
    Event Type
    Death
    Date Received
    September 16, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A LEAD EXTRACTION PROCEDURE TO REMOVE THREE LEADS DUE TO INFECTION. THE RV LEAD, BOSTON SCIENTIFIC ENDOTAK 0185-64 (IMPLANTED 35 MONTHS), WAS SUCCESSFULLY EXTRACTED WITH A 14F GLIDELIGHT WITH TEFLON OUTER SHEATH AND A COOK LIBERATOR. THE RA LEAD, BOSTON SCIENTIFIC DEXTRUS 4137-60 (IMPLANTED 35 MONTHS), WAS THEN EXTRACTED SUCCESSFULLY WITH TRACTION ALONE. THE LV LEAD, MEDTRONIC ATTAIN 4196 (IMPLANTED 35 MONTHS) WAS COMPLETELY EXTRACTED USING A 14F GLIDELIGHT WITHOUT OUTER SHEATH AND AN LLD-EZ. HOWEVER, WHEN THE PHYSICIAN LAZED THROUGH THE CORONARY SINUS AN INJURY OCCURRED. A PERICARDIOCENTESIS WAS PERFORMED AND THE CT SURGEON MADE A THORACIC WINDOW. THE PATIENT'S PRESSURE WAS NOT ABLE TO BE SUSTAINED AND UNFORTUNATELY HE DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571337 SPECTRANETICS GLIDELIGHT LASER SHEATH 14F GLIDELIGHT MFA SPECTRANETICS CORPORATION 500-302 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death MEDTRONIC ATTAIN 4196 LV LEAD (IMPL 35 MONTHS)| BOSTON SCIENTIFIC 4137-60 RA LEAD (IMPL 35 MONTHS)| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM| COOK LIBERATOR LOCKING STYLET| BOSTON SCIENTIFIC 0185-64 RV LEAD (IMPL 35 MONTHS)| SPECTRANETICS LEAD LOCKING DEVICE (LLD-EZ)