BEUDAMED
    FDA Adverse Event Other Summary report: N

    ROTABLADER ROTATIONAL ANGIOPLASTY SYSTEM

    MDR report key: 554529 · Received March 23, 2004

    Report

    Report Number
    554529
    Event Type
    Other
    Date Received
    March 23, 2004
    Date of Event
    October 1, 2003
    Report Date
    December 1, 2003
    Manufacturer
    SCIMED LIFE SYSTEMS, INC.
    Product Code
    MCX
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD A ROTATIONAL ANGIOPLASTY PROCEDURE, USING FIRST A 1.5 MM [MILLIMETER] BURR FOLLOWED BY A 2.0 BURR. BOSTON SCIENTIFIC REP [REPRESENTATIVE] WAS PRESENT DURING THE PROCEDURE. CARDIOLOGIST'S FOO[T] DISENGAGED FROM THE FOOT PEDAL AND THE BURR WAS STUCK IN THE CORONARY ARTERY. PT DEVELOPED PVCS [PREMATURE VENTRICULAR CONTRACTIONS] AND ELEVATED ST SEGMENTS. A BUDDY WIRE WITH 1.5 MM BALLOON, ROTAFLUSH WITH NITRO [NITROGLYCERIN]/VERAPAMIL AND INTRACORONARY NITRO BOLUS WAS ATTEMPTED, BUT THE BURR COULD NOT BE EASILY RETRACTED. RATHER THAN RISK SEVERE VESSEL INJURY AND CONCERN ABOUT MICROPERFORATION, THE PT WAS SENT TO O.R. [OPERATING ROOM] FOR EMERGENCY CABG [CORONARY ARTERY BYPASS GRAFT] X 3 [THREE TIMES] VESSELS WHILE HEMODYNAMICALLY STABLE WITH MININAL CHEST DISCOMFORT. PT LEFT POST-OP IN STABLE CONDITION AND WAS TRANSFERRED TO CCU [CORONARY CARE UNIT]. PT DISCHARGED 10/2003 [AND] STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLADER ROTATIONAL ANGIOPLASTY SYSTEM ANGIOPLASTY DEVICE MCX SCIMED LIFE SYSTEMS, INC. * 4673528

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other