BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK PLUS

    MDR report key: 1003410 · Received February 21, 2008

    Report

    Report Number
    2134265-2008-00510
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Report Date
    January 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED, HOWEVER, THE INFO PROVIDED STATES THAT THE HANDSHAKE CONNECTIONS BECAME SEPARATED DURING THE PROCEDURE AS A RESULT OF THE HANDSHAKE CONNECTIONS NOT BEING CONNECTED, AS OUTLINED IN THE ROTABLATOR DIRECTIONS FOR USE. IT IS ALSO UNK IF THE USER TESTED THE INTEGRITY OF THE ROTALINK UNIT OUTSIDE THE BODY AS OUTLINED IN THE DFU. THEREFORE, THE ROOT CAUSE OF THIS COMPLAINT IS USER/USE ERROR.

    Description of Event or Problem · 1

    SAME EVENT AS MFR REPORT #: 2134265-2008-00511. IT WAS REPORTED THAT "MID LAST YEAR" DURING A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE, A BURR STALLED IN THE LESION. DETAILS OF THE PROCEDURE AND PT ARE UNK. THE BURR WAS EXCHANGED DURING THE PROCEDURE, AND THE CATHETER THEN BECAME DETACHED AT THE HANDSHAKE CONNECTION DURING USE. A FEW ATTEMPTS WERE MADE TO RETRIEVE THE BURR AND IT WAS SUCCESSFULLY RETRIEVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTALINK PLUS MCX CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC

    Patients

    Seq Age Sex Outcome Treatment
    1