BEUDAMED
    FDA Adverse Event Death Summary report: N

    GLIDELIGHT LASER SHEATH

    MDR report key: 2884198 · Received December 21, 2012

    Report

    Report Number
    1721279-2012-00186
    Event Type
    Death
    Date Received
    December 21, 2012
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A LEFT SIDED CARDIAC LEAD EXTRACTION PERFORMED IN THE OR TO REMOVE 2 LEADS (MDT 6949 FIDELIS-RV & SJM 1688-RA; BOTH 72MTHS OLD) DUE TO A MALFUNCTIONING RA LEAD AND A PROPHYLACTIC REMOVAL OF THE RECALLED MDT 6949 FIDELIS. THE PATIENT WAS INTUBATED, RADIAL ARTERIAL LINE AND FEMORAL VENOUS LINES PLACED, AND PROTOCOL PER HRS RECOMMENDED STANDARDS. BOTH LEADS WERE PREPPED WITH A LLD-EZ AND LASING BEGAN ON THE RV LEAD WITH THE 14F GLIDELIGHT SHEATH SIGNIFICANT LEAD-ON-LEAD BINDING ENCOUNTERED IN THE SCV, LASING PROGRESSION WAS SLOW BUT CONSTANT. RESISTANCE WAS ENCOUNTERED AT THE DISTAL END OF THE PROXIMAL COIL AND THE PATIENT'S ABP BEGAN A STEADY DECLINE. AN EFFUSION WAS CONFIRMED VIA FLUOROSCOPY, CPR STARTED, TWO CVS ARRIVED WITHIN 2 MINUTES OF ABP DECLINE, BLOOD PRODUCTS INFUSED AND A STERNOTOMY PERFORMED WITHIN 15 MINUTES. UPON OPENING THE PATIENT'S CHEST A LARGE CLOT WAS REMOVED AND A JAGGED TEAR NOTED FROM THE MID-INNOMINATE TO THE RA. THE PATIENT WAS PLACED ON BYPASS AND PUT INTO A HYPOTHERMIC STATE DURING THE RESCUE. TWO CVS WORKED FROM 1040 TO 1800 REPAIRING THE ~8CM TEAR USING AN 18MM TUBE GRAFT. THE PATIENT WAS EVENTUALLY TRANSFERRED TO THE ICU AND IT WAS LATER DETERMINED THERE WAS NO BRAIN FUNCTION. THE FAMILY CHOSE TO REMOVE THE PATIENT FROM LIFE SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLIDELIGHT LASER SHEATH 14F GLIDELIGHT MFA SPECTRANETICS CORPORATION 500-302 FGY12J04B

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death CVX-300 EXCIMER LASER SYSTEM| SJM 1688| MDT 6949 FIDELIS| LLD-EZ