BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS GLIDELIGHT LASER SHEATH

    MDR report key: 3122689 · Received May 21, 2013

    Report

    Report Number
    1721279-2013-00066
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF RETURNED DEVICE: THE VISUAL INSPECTION OF THE DEVICE RETURNED FOUND NO DISCREPANCIES. NO FUNCTIONAL ISSUES IDENTIFIED, UNIT CALIBRATED PROPERLY. THE LOT HISTORY REPORT WAS REVIEWED WITH NO ISSUES OR NON-CONFORMANCES RELATED TO THE EVENT NOTED.

    Description of Event or Problem · 1

    THIS WAS A LEAD REMOVAL CASE PERFORMED IN THE EP LAB TO EXTRACT ONE SINGLE COIL MDT SPRINT 6931 LEAD PLACED IN 2001. THE PHYSICIAN BEGAN WITH A 14F GLIDELIGHT AND OUTER SHEATH. THE FLUENCE WAS INCREASED, BUT THE PHYSICIAN MADE LITTLE PROGRESS PASSED THE CLAVICLE. HE UPSIZED TO A 16F GLIDELIGHT WITH NO OUTER SHEATH. AS THE PHYSICIAN PROGRESSED PASSED THE SVC AND INTO ATRIUM, ANESTHESIST NOTED THERE WAS NO PRESSURE. THE OR TEAM SCRUBBED IN IMMEDIATELY, AND THE SURGEON DID A XYPHOID WINDOW TO DRAIN THE BLOOD. THE CHEST WAS THEN OPENED. THEY GAVE VOLUME AND TAMPONADED THE PERFORATION UNTIL THEY WERE ON BYPASS. THE LEAD WAS THEN REMOVED AND THE HOLE IN THE SVC WAS REPAIRED. PATIENT WAS TRANSFERRED TO ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224498 SPECTRANETICS GLIDELIGHT LASER SHEATH 16F GLIDELIGHT MFA SPECTRANETICS CORPORATION 500-303 FGC12F21A

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization| L| R 14F GLIDELIGHT| CVX-300 EXCIMER LASER (SN (B)(4))