BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS GLIDELIGHT LASER SHEATH

    MDR report key: 4122101 · Received September 26, 2014

    Report

    Report Number
    1721279-2014-00160
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 17, 2014
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A LEAD EXTRACTION CASE PERFORMED IN THE OPERATING ROOM TO REMOVE 5 VERY OLD (16 TO 22 YEARS) AND HEAVILY CALCIFIED LEADS. WHEN EXTRACTING THE LAST LEAD (MAKE AND MODEL UNKNOWN), THE PHYSICIAN UPSIZED FROM 14F TO 16F GLIDELIGHT BECAUSE HE COULD NOT ADVANCE THE SHEATH, BUT THE 16F SHEATH WAS STUCK AS WELL. HE THEN IDENTIFIED A PERFORATION, AND IMMEDIATELY OPENED THE CHEST. HE MADE A TAMPONADE, BUT IT DIDN'T WORK. A STERNOTOMY AND BYPASS WERE PERFORMED AND THE SVC PERFORATION WAS REPAIRED. PATIENT SURVIVED INTERVENTION, BUT IS STILL IN ICU DUE TO A BIG THROMBUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600669 SPECTRANETICS GLIDELIGHT LASER SHEATH 16F GLIDELIGHT MFA SPECTRANETICS CORPORATION 500-303 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| S CVX-300 EXCIMER LASER| 14F GLIDELIGHT