BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS LASER SHEATH II

    MDR report key: 1870844 · Received October 6, 2010

    Report

    Report Number
    1721279-2010-00061
    Event Type
    Injury
    Date Received
    October 6, 2010
    Report Date
    September 8, 2010
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING A CONVERSATION WITH A MEDICAL DEVICE SALES REPRESENTATIVE (NOT EMPLOYED BY SPNC), THE SPNC REPRESENTATIVE WAS INFORMED OF A LEAD REMOVAL CASE THAT OCCURRED APPROXIMATELY 6 WEEKS PRIOR TO 09/08/2010. THE MD REPORTEDLY USED A SLS (UNKNOWN SIZE) TO LASE THE CARDIAC LEAD OF THE PATIENT OF UNKNOWN GENDER, AGE OR WEIGHT. THE PATIENT'S VITAL SIGNS CHANGED (UNKNOWN LEVELS), EMERGENT INTERVENTION WAS INITIATED AND THE MD WAS REPORTEDLY ABLE TO REPAIR THE PATIENT'S INJURY (INNOMINATE VEIN TEAR) QUICKLY. THE PATIENT WAS REPORTED AS STABLE FOLLOWING THE PROCEDURE. THERE WERE NO REPORTS OF SPNC DEVICE(S) MALFUNCTION FROM THE ATTENDING PHYSICIAN OR HOSPITAL STAFF. NO DEVICES WERE RETAINED FOR RETURN ANALYSIS, THEREFORE, NO INTERNAL LOT HISTORY REVIEWS WERE ABLE TO BE CONDUCTED. REPEATED ATTEMPTS TO OBTAIN INFORMATION FROM THE HOSPITAL WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRANETICS LASER SHEATH II SLS II (UNKNOWN SIZE) MFA SPECTRANETICS CORP. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention CVX-300 EXCIMER LASER ((B)(4))