BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK? PLUS

    MDR report key: 4782032 · Received May 19, 2015

    Report

    Report Number
    2134265-2015-02907
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Date of Event
    January 27, 2015
    Report Date
    April 22, 2015
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR.: DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE COMPLAINT UNIT WAS CARRIED OUT AND NO ISSUES WERE NOTED. IT WAS NOTED THAT THE DISTAL COIL OF THE CATHETER UNIT HAD PLASTIC THREADS/FIBERS ATTACHED TO THE COIL. A TEST GUIDEWIRE COULD NOT BE LOADED THROUGH THE DEVICE DUE TO THE PLASTIC. THIS IS CONSISTENT THE ROTATING BURR COMING IN CONTACT WITH THE GUIDING CATHETER, CAUSING THE GUIDE CATHETER TO MELT ONTO THE DISTAL COIL, THEREFORE PREVENTING A GUIDEWIRE TO BE LOADED ONTO THE DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(4) 2015. IT WAS REPORTED THAT THE ROTAWIRE WAS UNABLE TO BE INSERTED INTO THE BURR. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED LEFT CIRCUMFLEX ARTERY. A 1.75MM ROTALINK¿ PLUS WAS SELECTED FOR USE. AFTER ROTA WIRE WAS CROSSED THE LESION, THE BURR WAS ATTEMPTED TO BE ADVANCED TO THE ROTAWIRE, HOWEVER IT WAS NOTED THAT THE ENTRANCE OF THE BURR HAD A PROBLEM BECAUSE IT WAS UNABLE TO INSERT THE ROTAWIRE INTO THE BURR. THE PROCEDURE WAS COMPLETED WITH A 1.50MM ROTALINK¿ PLUS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED PLASTIC THREADS/FIBERS ATTACHED TO THE DISTAL COIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324426 ROTALINK? PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310040 0016823775

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR GUIDE WIRE: ROTAWIRE