BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK PLUS

    MDR report key: 1213722 · Received October 22, 2008

    Report

    Report Number
    2134265-2008-03099
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 15, 2008
    Report Date
    September 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE, CATHETER DAMAGE OCCURRED. THE 90% STENOSED AND CALCIFIED LESION BEING TREATED WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. AFTER ADVANCING THE ROTAWIRE GUIDE WIRE, THE PHYSICIAN TESTED THE ROTABLATOR ROTALINK PLUS SYSTEM OUTSIDE OF THE PT WITHOUT DIFFICULTIES. THE PHYSICIAN THEN ADVANCED THE 1.5 MM BURR TO THE LESION; HOWEVER, WHEN THE PHYSICIAN TRIED TO BEGIN THE ROTATIONAL ATHERECTOMY, THE BURR WOULD NOT SPIN. THE PHYSICIAN NOTICED THAT THE CATHETER SHEATH WAS "BROKEN". THE PHYSICIAN REMOVED THE DEVICE AS ONE UNIT WITHOUT INCIDENT. THE PHYSICIAN THEN COMPLETED THE PROCEDURE WITH ANOTHER OF THE SAME ROTALINK SYSTEMS AND THE SAME GUIDE WIRE. NO PT COMPLICATIONS WERE REPORTED, AND PT STATUS WAS REPORTED AS 'STABLE'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTALINK PLUS MCX CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC NA 11747974

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR MEDTRONIC 7F EBU GUIDING CATHETER