BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SGW STAB PLUS .014 300CM JSS

    MDR report key: 199924 · Received December 2, 1998

    Report

    Report Number
    1016427-1998-00430
    Event Type
    Malfunction
    Date Received
    December 2, 1998
    Date of Event
    February 11, 1998
    Report Date
    December 2, 1998
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROXIMAL DIAGONAL LESION WAS EASILY WIRED AND STENTED WITHOUT DIFFICULTY. UPON WITHDRAWAL, THE WIRE WAS NOTED TO BE FRACTURED. FLUOROSCOPY CONFIRMED THE TIP OF THE WIRE REMAINED WITHIN A VERY SMALL SIDE-BRANCH. NO INTERVENTION WAS ATTEMPTED OR ANTICIPATED. PT ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SGW STAB PLUS .014 300CM JSS INTERVENTIONAL WIRES DQX CORDIS CORPORATION NA A0898836

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN