BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASER STAR WITH FUSED TIP

    MDR report key: 222255 · Received April 30, 1999

    Report

    Report Number
    2020638-1999-00012
    Event Type
    Malfunction
    Date Received
    April 30, 1999
    Date of Event
    March 31, 1999
    Report Date
    March 31, 1999
    Manufacturer
    CORDIS WEBSTER INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UPON CLEANING OF LASER STAR CATHETER LOT RD808W57, CATHETER NUMBER 2, BLOOD WAS SEEN OOZING FROM A TINY HOLE NEAR THE TIP OF THE CATHETER. VISUAL INSPECTION REVEALED TWO SMALL HOLES IN THE CATHETER. ONE SMALL NEAR THE TIP AND ONE LARGER FURTHER UP THE CATHETER THAT APPEARS TO HAVE FIBER WORN THROUGH. MD'S NOTIFIED AND CATHETER VIEWED. NO INDICATION DURING THE PROCEDURE THERE WAS A PROBLEM AND NO DEVICE MALFUNCTION APPARENT. THERE WAS NO LASER ENERGY LOSS OF CATHETER TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASER STAR WITH FUSED TIP THERAPUTIC CATHETER DQO CORDIS WEBSTER INC. D-1209-09-SI RD808W57

    Patients

    Seq Age Sex Outcome Treatment
    1 *