BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASER STAR WITH FUSE TIP

    MDR report key: 222085 · Received April 30, 1999

    Report

    Report Number
    2020638-1999-00013
    Event Type
    Malfunction
    Date Received
    April 30, 1999
    Date of Event
    November 21, 1998
    Report Date
    November 23, 1998
    Manufacturer
    CORDIS WEBSTER, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING THE SUBSEQUENT 24-48 HOUR POST OPERATION PERIOD, PT HAD A MINOR EMBOLIC STROKE TO THE RIGHT MIDBRAIN. THIS WAS PRESUMED TO BE EMBOLIC FROM THE ATTEMPT TO CROSS HER AORTIC VALVE, SEVERELY CALCIFIED, DURING THE "NOGA" MAPPING. PT NOTED MILD DYSARTHRIA, RIGHT FACIAL DROOP, AND MINOR LEFT-SIDED WEAKNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASER STAR WITH FUSE TIP THERAPUTIC CATHETER DQO CORDIS WEBSTER, INC. D-1209-09-SI RD808W58

    Patients

    Seq Age Sex Outcome Treatment
    1 * Disability