BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRANETICS

    MDR report key: 1972672 · Received January 21, 2011

    Report

    Report Number
    MW5019135
    Event Type
    Malfunction
    Date Received
    January 21, 2011
    Date of Event
    December 15, 2010
    Report Date
    January 21, 2011
    Manufacturer
    SPECTRANETICS
    Product Code
    LPC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TIP OF LASER FIBER BROKE OFF IN PT'S ARTERY. EXTENDED ENDOVASCULAR INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRANETICS TURBO-TANDEM LPC SPECTRANETICS FBX10G20B

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR