BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDELIGHT LASER SHEATH

    MDR report key: 2838784 · Received November 19, 2012

    Report

    Report Number
    1721279-2012-00164
    Event Type
    Injury
    Date Received
    November 19, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    SPECTRANETICS CORPORATION.
    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

    DEVICE WAS DISCARDED AND NOT RETURNED.

    Description of Event or Problem · 1

    THIS WAS A LEAD MANAGEMENT CASE THAT RESULTED IN AN SVC TEAR. THE EP WAS EXTRACTING AN MDT 6947 (QUATTRO) THAT HAD BEEN FRACTURED, USING AN LLD-EZ ((B)(4)). THE EP WAS LASING WITH A GLIDELIGHT 16FR. SIX SECONDS INTO THE SECOND LASER TRAIN, THE EP MET SOME RESISTANCE AND THE ABP DROPPED. AT THAT POINT, THE EP SUSPECTED TAMPONADE, CALLED THE ECHO TEAM, AND ASKED FOR A PERICARD TRAY. THEY WITHDREW ABOUT 400 ML OF BLOOD. THE EP RECOGNIZED THAT MORE THAN A TAMPONADE HAD OCCURRED AND CALLED THE CV SURGEON. THE ECHOCARDIOGRAM DID NOT SHOW THE TEAR. THE PATIENT WAS TRANSFERRED TO THE HYBRID OR. THE CHEST WAS OPENED 30 MINUTES AFTER THE ABP DROP, AND THE PATIENT WAS PUT ON BYPASS. THE SVC TEAR WAS ABOUT 1-1/2 INCHES LONG. THE PATIENT BLED OUT (COLD ARREST) AND HAS MASSIVE BRAIN DAMAGE, IS IN A COMA, AND IS RECOVERING PHYSICALLY BUT BRAIN ACTIVITY IS MINIMAL. THE CAPPED LEAD IS STILL IN THE BODY WITH THE LLD. LEAVING THE LLD IN THE BODY IS ADDRESSED IN AE 1721279-2012-00172. THE COMPANY WILL PROVIDE RETRAINING IN COMPLICATION AND PREVENTIVE MANAGEMENT TO THE HOSPITAL. A CHECKLIST FOR USE OF FACILITIES AND EQUIPMENT IS RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLIDELIGHT LASER SHEATH GLIDELIGHT 16FR OR GL MFA SPECTRANETICS CORPORATION. 500-303 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| R| S LLD-EZ: MODEL 518-062| QUATTRO MDT: 6947| CVX 300 EXCIMER LASER: (SN (B)(4))