BEUDAMED
    FDA Adverse Event Other Summary report: N

    ROTAGLIDE

    MDR report key: 279675 · Received May 24, 2000

    Report

    Report Number
    MW1018998
    Event Type
    Other
    Date Received
    May 24, 2000
    Report Date
    May 24, 2000
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    MCX
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO RPTR ROTAGLIDE IS AN FDA APPROVED DEVICE FOR USE IN ROTABLATOR PROCEDURES TO REMOVE PLAQUES FROM CORONARY ARTERIES. THE PRODUCT IS APPROVED AS A DEVICE EVEN THOUGH IT IS IN AN EGG-BASED SOLUTION SIMILAR TO LIPID SOLUTIONS. THE "DEVICE" IS DILUTED IN NORMAL SALINE AND IS INFUSED INTO THE ROTABLATOR AS IT WORKS ITS WAY THROUGH THE PLAQUE. THE SOLUTION IS "THUG" IN THE PT CIRCULATION. THERE IS A TREMENDOUS RISK TO THE PT FROM AN ALLERGIC REACTION IF THEY ARE EGG ALLERGIC. SINCE THIS WAS APPROVED AS A DEVICE, THERE IS NO DRUG INFO AS TO THE STABILITY OF THIS "DEVICE" IN SOLUTION, NO INFO AS TO ANY POSSIBLE SIDE EFFECTS, ANY OTHER PRECAUTIONS. RPTR ASKS HOW THIS EVER GOT APPROVED AS A DEVICE. RPTR STATES THAT THIS IS A DRUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTAGLIDE SOLUTION MCX BOSTON SCIENTIFIC CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other