BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTALINK EXCHANGEABLE CATHETER

    MDR report key: 1161716 · Received September 9, 2008

    Report

    Report Number
    1161716
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    August 26, 2008
    Report Date
    September 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ROTABLATOR BURR 1.50 MM ROTALINK EXCHANGEABLE CATHETER (BOSTON SCIENTIFIC) WAS WITHDRAWN NOTED THE FLUSH SOLUTION WAS SQUIRTING OUT A HOLE IN THE SHAFT OF THE CATHETER AND NOT OUT THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTALINK EXCHANGEABLE CATHETER CATHETER, ARTHRECTOMY MCX BOSTON SCIENTIFIC UP#H802227680030 11818789

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR CARDIAC DRUGS| CARDIAC DRUGS