BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.3 OVER THE WIRE TURBO ELITE

    MDR report key: 2010952 · Received March 4, 2011

    Report

    Report Number
    1721279-2011-00010
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 10, 2011
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MCW
    PMA / PMN Number
    K071227
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT PRESENTED WITH A 90%, SHORT OCCLUSION OF THE SFA. THE PHYSICIAN CHOSE A 2.3 TE OTW AND BEGAN LASING IN THE OCCLUDED VESSEL. AFTER THE 3RD LASING RUN, A DISSECTION WAS NOTED ON FLUOROSCOPY. THE PHYSICIAN REMOVED THE TE DEVICE, BALLOONED AND STENTED THE VESSEL AND SUCCESSFULLY CONTAINED THE DISSECTION. BLOOD FLOW WAS RESTORED TO THE VESSEL AND THE PT RECOVERED WITHOUT ANY FURTHER REPORTED COMPLICATIONS. THE DEVICE WAS DISCARDED AFTER USE IN THE HYBRID OPERATING ROOM AND THEREFORE WAS NOT RETURNED TO THE MFR FOR ANALYSIS. AN INTERNAL LHR REVIEW WAS PERFORMED AND SHOWED NO NON-CONFORMANCES OR ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.3 OVER THE WIRE TURBO ELITE TE OTW 2.3 MCW SPECTRANETICS CORP. 423-001 C09C19A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention CVX-300 EXCIMER LASER SYSTEM: (B)(6)