BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS GLIDELIGHT LASER SHEATH

    MDR report key: 4201327 · Received October 27, 2014

    Report

    Report Number
    1721279-2014-00169
    Event Type
    Death
    Date Received
    October 27, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    SPECTRANETICS CORPORTATION
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LEAD MANAGEMENT CASE TO EXTRACT ONE MDT 6949 LEAD DUE TO AN INCREASE IN SVC IMPEDANCE. THE PHYSICIAN PREPPED THE LEAD WITH AN LLD THEN STARTED THE EXTRACTION WITH A 14F GLIDELIGHT AND VISISHEATH. HEAVY CALCIFICATION WAS ENCOUNTERED AT THE CLAVICLE AND THE PHYSICIAN UPSIZED TO A 16F GLIDELIGHT AND VISISHEATH; CONTINUING THE PROCEDURE. WHILE ADVANCING THE 16F GLIDELIGHT OVER THE SVC COIL THE PATIENT'S BLOOD PRESSURE DROPPED. A STERNOTOMY WAS PERFORMED REVEALING THAT THE LEAD HAD GROWN INTO THE VASCULAR WALL CAUSING DAMAGE TO THE WALL OF THE VESSEL DURING EXTRACTION. UNFORTUNATELY RESCUE EFFORTS WERE NOT SUCCESSFUL AND THE PATIENT DID NOT SURVIVE THE INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683159 SPECTRANETICS GLIDELIGHT LASER SHEATH 16F GLIDELIGHT MFA SPECTRANETICS CORPORTATION 500-303 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM| MDT 6949 CARDIAC LEAD (IMPL. 84 MO)| MDT 4193 CARDIAC LEAD (IMPL. 84 MO)| SPECTRANETICS 14F GLIDELIGHT LASER SHEATH| SPECTRANETICS VISISHEATH DILATOR SHEATH| MDT 4076 CARDIAC LEAD (IMPL. 84 MO)