BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEGASUS MODERATE SUPPORT GUIDEWIRE

    MDR report key: 1549507 · Received November 10, 2009

    Report

    Report Number
    3003778388-2009-00001
    Event Type
    Malfunction
    Date Received
    November 10, 2009
    Date of Event
    September 14, 2009
    Report Date
    November 10, 2009
    Manufacturer
    STEREOTAXIS, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RETURNED TO THE (B)(4) MFG SITE AND EVALUATED. THE RESULTS OF THAT INVESTIGATION REVEALED NO PRODUCT DEFICIENCIES OR FAILURES FOUND.

    Description of Event or Problem · 1

    THE PEGASUS MODERATE SUPPORT WIRE BROKE OFF APPROX 2CM PROXIMALLY TO THE TIP IN THE MID RCA, REQUIRING 2 STENTS TO ISOLATE IT BETWEEN THE STRUTS AND THE VESSEL WALL. NO CLINICAL COMPLICATIONS. PT WAS TRANSFERRED TO THE POST PROCEDURE AREA IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEGASUS MODERATE SUPPORT GUIDEWIRE GUIDEWIRE DQX STEREOTAXIS, INC. 001-001671-9 P1410877

    Patients

    Seq Age Sex Outcome Treatment
    1