BEUDAMED
    FDA Adverse Event Death Summary report: N

    TURBO ELITE 2.3MM

    MDR report key: 1725483 · Received June 10, 2010

    Report

    Report Number
    1721279-2010-00027
    Event Type
    Death
    Date Received
    June 10, 2010
    Date of Event
    May 13, 2010
    Report Date
    June 10, 2010
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER DATES FOR ALL DEVICES: UNKNOWN.

    Description of Event or Problem · 1

    INDICATION FOR PROCEDURE: CHRONIC TOTAL OCCLUSION OF THE SFA. PROCEDURE: MD TREATED A CTO OF THE SFA IN A PATIENT SUCCESSFULLY WITH A 2.3 TURBOELITE ON (B) (6) 2010. THREE DAY LATER ((B) (6) 2010) THE SPNC REPRESENTATIVE WAS NOTIFIED THAT THE PATIENT SUFFERED A POST-OPERATIVE CEREBRAL HEMORRHAGE AND UNFORTUNATELY EXPIRED. THE MD STATED, HE DOES NOT BELIEVE THE SPNC DEVICE WAS RELATED TO THE PATIENT'S POST-OPERATIVE CRANIAL BLEED. THERE WERE NO REPORTED MALFUNCTIONS OF THE SPNC DEVICE DURING THE (B) (6) 2010 CASE. THE DEVICE WAS NOT RETAINED FOR RETURN ANALYSIS; THE SERIAL # OF THE TE 2.3 IS UNKNOWN. AN ONGOING INVESTIGATION IS BEING CONDUCTED TO OBTAIN FURTHER INFORMATION REGARDING THE DETAILS SURROUNDING THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TURBO ELITE 2.3MM TE 2.3 GEX SPECTRANETICS CORPORATION 423-001 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death GENERATION 4 EXCIMER LASER