BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.3 TURBO ELITE

    MDR report key: 1073643 · Received July 11, 2008

    Report

    Report Number
    1721279-2008-00015
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    April 28, 2008
    Report Date
    June 10, 2008
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO SPECTRANETICS FOR INVESTIGATION. NO DEVICE MALFUNCTION WAS REPORTED.

    Description of Event or Problem · 1

    A FEMALE WAS TREATED FOR A TOTAL OCCLUSION IN THE PROXIMAL SFA. A GUIDE WIRE AND A 2.3 MM OTW TURBO ELITE LASER CATHETER WAS USED IN A STEP BY STEP FASHION IN AN ATTEMPT TO CROSS THE OCCLUSION. AFTER SEVERAL ATTEMPTS TO CROSS THE OCCLUSION, UNSUCCESSFULLY, A FLUOROSCOPY IMAGE REVEALED A PERFORATION IN THE VESSEL. IT WAS UNKNOWN TO THE PHYSICIAN IF THE PERFORATION WAS CAUSED BY THE GUIDE WIRE, THE LASER CATHETER OR A CALCIFIED LESION FRAGMENT. AFTER AN UNSUCCESSFUL ATTEMPT AT BALLOONING THE PERFORATION, THE PHYSICIAN DEPLOYED TWO VIABAHN STENT GRAFTS TO COVER THE ENTIRE PERFORATION. A SUBSEQUENT REVEALED A LARGE (3-5CM) PSEUDOANEURYSM AT THE DISTAL END OF THE SECOND VIABAHN STENT GRAFT. MULTIPLE COILS WERE DELIVERED TO OCCLUDE THE VIABAHN STENT GRAFT AND THEN THE PROCEDURE WAS TERMINATED. THE PATIENT WAS GIVEN 4 UNITS OF BLOOD AND WAS THEN RELEASED AFTER FOUR DAYS IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.3 TURBO ELITE TURBO ELITE LASER CATHETER OTW GEX SPECTRANETICS CORP. 423-001

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention SPECTRANETICS CVX-300 LASER