BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC-SCIMED

    MDR report key: 444624 · Received February 25, 2003

    Report

    Report Number
    444624
    Event Type
    Injury
    Date Received
    February 25, 2003
    Date of Event
    December 20, 2002
    Report Date
    December 31, 2002
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NFN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    HI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING ROTABLATION OF RIGHT CORONARY ARTERY SCIMED FLOPPY WIRE WAS USED WITH 1.5MM BURR STANDARD TECHNIQUE WITH PLATFORMING OUTSIDE AND INSIDE BODY. 6 RUNS (ROTABLATOR) PERFORMED AT 155-160,000 RPM FOR 10-25 SECONDS. 7TH RUN WIRE BROKE. UNABLE TO RETRIEVE. PT WENT TO CABG X1 AND WIRE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC-SCIMED ROTABLATOR GUIDE WIRE-ROTAWIRE FLOPPY NFN BOSTON SCIENTIFIC ROTAWIRE (TM) FLOPPY-325CM 4345156

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening