BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTALINK PLUS

    MDR report key: 3029361 · Received January 24, 2013

    Report

    Report Number
    3029361
    Event Type
    Malfunction
    Date Received
    January 24, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC CORP
    Product Code
    MCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    DURING A ROTATIONAL ATHERECTOMY OF LEFT ANTERIOR DESCENDING ARTERY(LAD), ROTA DEVICE WAS INSERTED AND ROTA PASS ATTEMPTED TWICE BY DOCTOR. DEVICE WAS THEN REMOVED AND TWO RADIOPAQUE FOREIGN BODIES WERE NOTED IN LAD. DOCTOR WAS UNABLE TO SNARE FOREIGN OBJECTS FROM LAD.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ROTATIONAL ATHERECTOMY OF LAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35134 ROTABLATOR ROTALINK PLUS CATHETER, PERIPHERAL, ARTHERECTOMY MCW BOSTON SCIENTIFIC CORP 23631-002 15390233
    35135 ROTABLATOR ROTAWIRE CATHETER, PERIPHERAL, ARTHERECTOMY MCW BOSTON SCIENTIFIC CORP 22824-002 14486159
    35136 ROTABLATOR ROTAWIRE CATHETER, PERIPHERAL, ARTHERECTOMY MCW BOSTON SCIENTIFIC CORP * 15259393

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR