BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS LEAD LOCKING DEVICE

    MDR report key: 3250298 · Received July 26, 2013

    Report

    Report Number
    1721279-2013-00107
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    July 17, 2013
    Report Date
    July 17, 2013
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    DRB
    PMA / PMN Number
    K043401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING REMOVAL OF 3 IMPLANTED LEADS. RV AND RA WERE SUCCESSFULLY REMOVED (MEDTRONIC SPRINT FIDELIS 6949 AND MEDTRONIC CAPSURE SP NOVUS 4592, RESPECTIVELY). THE LV (BOSTON SCIENTIFIC EASYTRAK 3 GDT 4548) WAS THEN PREPPED WITH AN LLD-EZ. THE PHYSICIAN ADVANCED TO THE DISTAL SEGMENT OF THE LV LEAD, WHICH AT THIS POINT WAS AT THE CORONARY SINUS OSTIUM. THE PHYSICIAN DISCONTINUED USE OF THE LASER AND MAINTAINED TRACTION WITH THE LLD-EZ. THE LEAD EVENTUALLY CAME FREE. THERE WAS A DECLINE IN THE PATIENT'S PRESSURE FROM APPROXIMATELY 100S TO 70S. THE CT WAS CALLED AND A PERICARDIAL WINDOW WAS USED AFTER EVALUATION AND NOTATION OF AN EFFUSION BY ECHO. THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351238 SPECTRANETICS LEAD LOCKING DEVICE LLD-EZ DRB SPECTRANETICS CORPORATION 518-062 FLP13E28A

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| L| R SPECTRANETICS VISISHEATH DILATOR SHEATH| SPECTRANETICS CXV-300 EXCIMER LASER| MEDTRONIC SPRINT FIDELIS 6949| BOSTON SCIENTIFIC EASYTRAK 3 GDT 4548| MEDTRONIC CAPSURE SP NOVUS 4592| SPECTRANETICS GLIDELIGHT LASER SHEATH