BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR GUIDEWIRE

    MDR report key: 444636 · Received February 25, 2003

    Report

    Report Number
    6000119-2003-00001
    Event Type
    Injury
    Date Received
    February 25, 2003
    Date of Event
    December 20, 2002
    Manufacturer
    BOSTON SCIENTIFIC MIAMI TECHNOLOGY CENTER
    Product Code
    NFN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE OF AN RCA LESION, THE TIP OF THE WIRE FRACTURED. THE FLOPPY ROTAWIRE WAS USED WITH A 1.5MM BURR UTILIZING STANDARD TECHNIQUE WITH PLATFORMING BOTH OUTSIDE AND INSIDE THE BODY. SIX RUNS WERE SUCCESSFULLY COMPLETED WITH THE ROTABLATOR AT SPEEDS OF 155,000-160,000 RPM'S FOR 10-25 SECONDS. DURING THE SEVENTH RUN, THE WIRE TIP FRACTURED. ATTEMPTS WERE MADE AT RETRIEVAL WHICH WERE UNSUCCESSFUL. THE PT WAS SENT TO SURGERY FOR SINGLE VESSEL BYPASS AND SUCCESSFUL REMOVAL OF THE WIRE TIP. PT IS REPORTED AS "OKAY" FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR GUIDEWIRE ROTABLATOR GUIDEWIRE NFN BOSTON SCIENTIFIC MIAMI TECHNOLOGY CENTER FLOPPY RTW 4345156

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| R