BEUDAMED
    FDA Adverse Event Death Summary report: N

    GLIDELIGHT LASER SHEATH

    MDR report key: 2950023 · Received February 8, 2013

    Report

    Report Number
    1721279-2013-00012
    Event Type
    Death
    Date Received
    February 8, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A CARDIAC LEAD EXTRACTION PERFORMED IN THE O.R TO PROPHYLACTICALLY REMOVE A 5YO, FUNCTIONAL SJM 1581 RIATA -RV PER PATIENT'S WISHES. THE PATIENT ALSO HAD A RA LEAD THAT WOULD BE REMOVED. THE PATIENT WAS PREPPED PER HRS RECOMMENDED STANDARDS WITH A CVS ON STANDBY. THE RV LEAD WAS PREPPED WITH A LLD-EZ AND LASING BEGAN WITH A 16F GLIDELIGHT. THE MD BEGAN LASING AT 80HZ THROUGH THE SCV, DIALING THE LASER DOWN TO 40HZ THROUGH THE INNOMINATE/SVC, UPON REACHING THE PROXIMAL COIL DIALED THE LASER TO 60HZ, AND RETURNED TO 80HZ WHILE APPROACHING THE SVC/RA JUNCTION. THE PATIENT'S ABP TOOK A SHARP DECLINE FROM A BASELINE OF ~90 TO ~40. THE CVS AND PERFUSIONIST WERE PAGED IMMEDIATELY. THE CVS ENTERED THE ROOM WITHIN 2 MINUTES, BLOOD WAS HUNG AND A STERNOTOMY PERFORMED WITHIN 5 MINUTES OF THE INITIAL ABP DECLINE. PERFUSION WAS IN THE ROOM WITHIN 7 MINUTES WITH BYPASS READY. UPON OPENING THE CHEST, IT WAS NOTED THE TEAR BEGAN IN THE SCV, INTO THE IJ AND DOWN TO THE DISTAL SVC AND THE PATIENT'S VASCULATURE APPEARED VERY BRITTLE IN NATURE. THE CVS STATED THE SJM 1581 WAS ADHERED TO THE VASCULATURE, AS THE TEAR MIMICKED THE LEAD PLACEMENT. THE TEAM WORKED FOR ~ 60 MINUTES ATTEMPTING TO REPAIR THIS SIGNIFICANT TEAR BUT WAS ULTIMATELY UNSUCCESSFUL AND THE PATIENT DIED ON THE TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53952 GLIDELIGHT LASER SHEATH 16F GLIDELIGHT MFA SPECTRANETICS CORPORATION 500-303 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death CVX-300 EXCIMER LASER| RA LEAD UNKNOWN| SJM 1581 RIATA| LLD-EZ