BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK? PLUS

    MDR report key: 3910118 · Received July 2, 2014

    Report

    Report Number
    2134265-2014-03805
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE DEVICE WAS RETURNED FOR EVALUATION. THE ADVANCER WAS CONNECTED TO THE CATHETER. THE ADVANCER KNOB WAS RETURNED INDEPENDENTLY TO THE COMPLAINT DEVICE. THE ADVANCER KNOB WAS REATTACHED AND ADVANCED IN ORDER TO INSPECT THE HANDSHAKE CONNECTION. THE HANDSHAKE CONNECTION WAS INSPECTED AND NO DAMAGE WAS NOTED. A HANDSHAKE CONNECTION TEST WAS ATTEMPTED TO EXAMINE THE INTEGRITY OF THE CONNECTION AND NO ISSUES WERE NOTED. THE DRIVE SHAFT WAS INSPECTED AND THERE WAS NO DAMAGE NOTED. A TEST GUIDEWIRE WAS ATTEMPTED TO BE INSERTED INTO THE BURR OF THE CATHETER BUT THIS WAS UNSUCCESSFUL AS THE ANNULUS WAS BLOCKED WITH DRIED SALINE AND WAS FOUND TO BE DAMAGED. 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).

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2014-03744. IT WAS REPORTED THAT A WIRE SEPARATION OCCURED. A ROTALINK¿ PLUS AND ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WERE SELECTED TO TREAT THE SEVERELY CALCIFIED TARGET LESION. DURING PREPARATION, TEST ABLATION WAS PERFORMED OUTSIDE THE PATIENT. IT WAS NOTED THAT THE WIRE GOT SEPARATED. PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2014-03744. IT WAS REPORTED THAT A WIRE SEPARATION OCCURED. A ROTALINK¿ PLUS AND ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WERE SELECTED TO TREAT THE SEVERELY CALCIFIED TARGET LESION. DURING PREPARATION, TEST ABLATION WAS PERFORMED OUTSIDE THE PATIENT. IT WAS NOTED THAT THE WIRE GOT SEPARATED. PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386970 ROTALINK? PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310030 16366285

    Patients

    Seq Age Sex Outcome Treatment
    1