BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS LASER SHEATH

    MDR report key: 1353792 · Received March 26, 2009

    Report

    Report Number
    1721279-2009-00014
    Event Type
    Death
    Date Received
    March 26, 2009
    Date of Event
    March 3, 2009
    Report Date
    March 3, 2009
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS: THE SPECTRANETICS DEVICE USED DURING THE PROCEDURE WAS DISCARDED AT THE HOSPITAL AND WILL NOT BE RETURNED FOR EVALUATION. THERE IS NO INDICATION THAT THE TEAR WAS CAUSED BY THE SPECTRANETICS DEVICE.

    Description of Event or Problem · 1

    CLINICAL HISTORY: THE PROCEDURE WAS REQUIRED TO REMOVE THREE FUNCTIONAL LEADS DUE TO POCKET INFECTION. IT WAS A LEFT SIDED PROCEDURE. RA MODEL 438-10 THINLINE POSITIVE FIX IMPLANTED 1999. RV MODEL 0144 ENDOTAK ENDURANCE PASSIVE IMPLANTED 1999. LV MODEL 4513 IMPLANTED 2004. PROCEDURE: THE PROCEDURE WAS PERFORMED IN THE EP LAB. AN ATRIAL LINE AND FLURO WERE USED THROUGHOUT THE PROCEDURE. THE LV LEAD WAS SUCCESSFULLY REMOVED. A TEAR OCCURRED WHILE USING THE LASER AND A 16FR SLS CATHETER TO REMOVE THE RV DEFIBRILLATOR LEAD. IT WAS BELIEVED TO HAVE OCCURRED WHILE LASING THE PROXIMAL COIL OF THE LEAD AT THE SUPERIOR VENA CAVA/RIGHT ATRIUM JUNCTION. CT SURGERY RESPONDED AND THE DECISION WAS MADE TO OPEN THE PT'S CHEST. THE PATIENT EXPIRED DURING THE REPAIR PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRANETICS LASER SHEATH SLS II, 16FR MFA SPECTRANETICS CORP. 500-013 080414B24/080213A1

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death GEN.4.0 EXCIMER LASER