BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS GLIDELIGHT LASER SHEATH

    MDR report key: 3140771 · Received May 31, 2013

    Report

    Report Number
    1721279-2013-00082
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    April 11, 2013
    Report Date
    May 9, 2013
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED MAUDE EVENT REPORT FROM FDA ON 22JULY2013 AND NOTED THE EVENT DATE WAS DIFFERENT THAN INITIALLY REPORTED. CALLED THE FACILITY CONTACT ON MW5030605 ON 23JUL2013, AND CONFIRMED THAT THE EVENT DATE INITIALLY PROVIDED WAS INCORRECT. THIS REPORT CORRECTS THE EVENT DATE FROM (B)(6) 2013.

    Description of Event or Problem · 1

    THIS WAS A LEAD MANAGEMENT CASE CONDUCTED IN THE EP LAB TO REMOVE TWO LEADS (MDT 6947 AND AN UNKNOWN). THE SURGEON BEGAN WITH A 14F GLIDELIGHT LASER SHEATH. DURING THE CASE, THE MDT 6947 LEAD FRACTURED. THE 14F GLIDELIGHT LASERED THROUGH THE SVC/RA JUNCTION. A STERNOTOMY WAS PERFORMED AND THE INJURY WAS REPAIRED. DUE TO THE EMERGENT SURGERY, THE MDT 6947 WAS ABANDONED IN THE PATIENT WITH THE LLD INSIDE. PATIENT WAS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242467 SPECTRANETICS GLIDELIGHT LASER SHEATH 14F GLIDELIGHT MFA SPECTRANETICS CORPORATION 500-302 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization| L| R MDT 6947 LEAD| CVX-300 EXCIMER LASER (SN (B)(4))| LLD