BEUDAMED
    FDA Adverse Event Death Summary report: N

    GLIDELIGHT LASER SHEATH

    MDR report key: 2863111 · Received December 10, 2012

    Report

    Report Number
    1721279-2012-00183
    Event Type
    Death
    Date Received
    December 10, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    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 CARDIAC LEAD REMOVAL CONDUCTED IN THE OR TO REMOVE ONE ICD LEAD -RV (ENDOTAK RELIANCE G 175) DUE TO IMPEDANCE CHANGES. PATIENT WAS INTUBATED, ARTERIAL LINE STARTED, FLUOROSCOPY AND TEE IN USE, AND CVS ON CALL. THE RV LEAD WAS PREPPED WITH A LLD# 2 AND LASING BEGAN WITH A 16F GLIDELIGHT (GL) WITH THE ADDITION OF A L - VISISHEATH 33CM. THE EP WAS OPERATING THE LASER PEDAL, A CARDIOLOGY FELLOW WAS HOLDING TRACTION ON THE LLD #2 AND AN EP FELLOW WAS HANDLING THE 16F GL AND THE VISISHEATH. ADVANCEMENT OF THE 16F GL PROGRESSED TO THE SVC WHEN IT WAS NOTED THE GL WAS FLUSH WITH THE SVC WALL. AT THIS TIME THE EP TOOK CONTROL OF THE LLD #2, PULLED THE ENTIRE LASER SHEATH BACK TO THE INNOMINATE AND IT WAS AT THIS TIME THE PATIENT'S ABP DROPPED. AN EFFUSION WAS NOTED AND THE EP REQUESTED A PERICARDIOCENTESIS TRAY AND THE CVS BE CALLED. THE PERICARDIOCENTESIS WAS PERFORMED WITHIN 2 MINUTES OF THE INITIAL ABP DROP; CPR WAS STARTED. THE CVS PERFORMED A STERNOTOMY, ULTIMATELY DETERMINING THE PATIENT'S INJURY WAS BEYOND REPAIR AND THE CODE WAS CALLED. THE PATIENT EXPIRED ON THE TABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death L - VISISHEATH 33CM| CPI-GUIDANT ENDOTAK RELIANCE G 175 DUAL COIL| CVX-300 EXCIMER LASER SYATEM| LLD #2