BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS GLIDELIGHT LASER SHEATH

    MDR report key: 3629578 · Received February 14, 2014

    Report

    Report Number
    1721279-2014-00029
    Event Type
    Injury
    Date Received
    February 14, 2014
    Date of Event
    February 12, 2014
    Report Date
    February 12, 2014
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A LEAD REMOVAL CASE PERFORMED IN A HYBRID OR TO EXTRACT ONE MDT 6949-65 CARDIAC LEAD FROM THE RV. THE CASE BEGAN WITH A 12F GLIDELIGHT LASER CATHETER AND THE LEAD WAS PREPPED WITH AN LLD-EZ. THE PHYSICIAN ENCOUNTERED TOUGH SCARRING ON THE SVC COIL OF THE LEAD, SO UPSIZED TO A 14F GLIDELIGHT LASER CATHETER. HE WAS ABLE TO ADVANCE THE CATHETER PAST THIS ADHESION INTO THE RV, WHEN THE BLOOD PRESSURE CHANGED. THE STAFF IMMEDIATELY CHANGED THE CASE TO A RESCUE, ALERTED THE SURGEON, AND WITHIN 5 MINUTES HAD PERFORMED A PERICARDIOCENTESIS. THIS CONTROLLED THE RESCUE UNTIL THE CHEST COULD BE OPENED. THE INJURY AT THE SVC/RA JUNCTION WAS IDENTIFIED AND REPAIRED. THE LEAD WAS REMOVED AT THIS TIME. THE PATIENT SURVIVED THE RESCUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98474 SPECTRANETICS GLIDELIGHT LASER SHEATH 14F GLIDELIGHT MFA SPECTRANETICS CORPORATION 500-302 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| L| R SPECTRANETICS 12F GLIDELIGHT| SPECTRANETICS CVX-300 EXCIMER LASER (SN (B)(4))| SPECTRANETICS LEAD LOCKING DEVICE LLD-EZ| MEDTRONIC 6949-65 CARDIAC LEAD