BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK? PLUS

    MDR report key: 3770907 · Received April 24, 2014

    Report

    Report Number
    2134265-2014-02171
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 28, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE DEVICE WAS RETURNED FOR ANALYSIS. THE ROTABLATOR PLUS UNIT WAS RETURNED CONNECTED TOGETHER. THE WIRE WAS ATTEMPTED TO BE INSERTED INTO THE BURR OF THE CATHETER BUT WAS UNSUCCESSFUL AS THE ANNULUS WAS BLOCKED WITH DRIED SALINE AND WAS FOUND TO BE DAMAGED. NO DAMAGE NOTED ON THE HANDSHAKE CONNECTION. A TUG TEST WAS PERFORMED TO EXAMINE THE INTEGRITY OF THE CONNECTION. NO ISSUES WERE NOTED WITH THE UNIT¿S HANDSHAKE CONNECTOR DURING THE CONNECTION OF THE DEVICE. THE UNIT WAS WET TESTED AND THE DEVICE WAS UNABLE TO REACH OPTIMUM SPEED AS THE DEVICE STALLED. THE UNIT WAS DISMANTLED AND THE ULTEM WAS FOUND TO BE MELTED. THERE WAS NO EVIDENCE OF A REMAINDER OF A GUIDEWIRE PRESENT IN THE UNIT WHEN THE UNIT WAS DISMANTLED HOWEVER, THE DAMAGE TO THE ANNULUS MAY SUGGEST THAT THE GUIDEWIRE MADE CONTACT WITH THE ANNULUS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED WITHOUT DIRECT PATIENT CONTACT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2014-02170. IT WAS REPORTED THAT THE ROTAWIRE SEPARATED. A 1.25MM ROTALINK PLUS AND ROTAWIRE FLOPPY WAS SELECTED TO TREAT THE TARGET LESION. DURING PLATFORMING OUTSIDE OF THE PATIENT, WHEN PHYSICIAN TRIED TO SET RPM, IT WAS NOTED THAT THE BURR CUT THE ROTAWIRE IN TWO PARTS. PROCEDURE WAS COMPLETED WITHOUT ROTABLATOR. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2014-02170. IT WAS REPORTED THAT THE ROTAWIRE SEPARATED. A 1.25MM ROTALINK PLUS AND ROTAWIRE FLOPPY WAS SELECTED TO TREAT THE TARGET LESION. DURING PLATFORMING OUTSIDE OF THE PATIENT, WHEN PHYSICIAN TRIED TO SET RPM, IT WAS NOTED THAT THE BURR CUT THE ROTAWIRE IN TWO PARTS. PROCEDURE WAS COMPLETED WITHOUT ROTABLATOR. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249306 ROTALINK? PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310020 0016576817

    Patients

    Seq Age Sex Outcome Treatment
    1