BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROTAWIRE

    MDR report key: 4143319 · Received September 16, 2014

    Report

    Report Number
    4143319
    Event Type
    Death
    Date Received
    September 16, 2014
    Date of Event
    August 25, 2014
    Report Date
    September 16, 2014
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MCX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT IS AN ELDERLY FEMALE WHO WAS FOUND TO HAVE EXTENSIVE 3-VESSEL CORONARY ARTERY DISEASE (CAD). SHE WAS CONSIDERED HIGH RISK FOR SURGERY AND AFTER MEDICAL MANAGEMENT OF HER CAD FAILED SHE UNDERWENT PERCUTANEOUS CORNARY INTERVENTION (PCI) OF THE LEFT CIRCUMFLEX ARTERY. HEAVY CALCIFICATION WAS PRESENT IN THE ARTERY AND ROTATIONAL ATHERECTOMY WITH A 1.25MM ROTABLATOR BURR WAS PERFORMED USING 5 PASSES AT A ROTATIONAL SPEED UP TO 180,000 RPM OVER AN ECCENTRIC PLAQUE. DURING THE FINAL POLISHING RUN, THE BURR PERFORATED THE LEFT CIRCUMFLEX ARTERY AND A BALLOON WAS INSERTED TO TAMPONADE THE LEAKING VESSEL. IT WAS THEN FOUND THAT THE ROTAWIRE CORONARY GUIDEWIRE, OVER WHICH THE ATHERECTOMY BURR WAS PLACED, HAD FRACTURED AND APPROXIMATELY 10CM OF THE DISTAL PORTION OF THE GUIDEWIRE REMAINED LODGED IN THE PROXIMAL CIRCUMFLEX ARTERY. ATTEMPTS WERE MADE TO SNARE THE WIRE FRAGMENT BUT WERE UNSUCCESSFUL. IT WAS THEN NOTED THAT THROMBUS WAS ACCUMULATING ON THE WIRE AND BALLOONS DESPITE THERAPEUTIC ANTICOAGULATION LEVELS. POOR FLOW WAS NOTED THROUGH THE LEFT CIRCUMFLEX AND OBTUSE MARGINAL BRANCH. THE PATIENT'S CONDITION DETERIORATED RAPIDLY AND SHE WAS UNABLE TO BE RESUSCITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572384 ROTAWIRE CORONARY GUIDEWIRE MCX BOSTON SCIENTIFIC CORPORATION * 16903017 OR 16910027

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death NO OTHER THERAPIES| A ROTATIONAL ATHERECTOMY BURR HAD BEEN ADVANCED| OVER THE GUIDEWIRE