BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 1675711 · Received May 6, 2010

    Report

    Report Number
    2134265-2010-02041
    Event Type
    Injury
    Date Received
    May 6, 2010
    Date of Event
    April 7, 2010
    Report Date
    April 14, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN; THEREFORE THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B) (4).

    Description of Event or Problem · 1

    SAME CASE AS MFR #: 2134265-2010-02153 AND 2134265-2010-202154. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY PROCEDURE, REMOVAL DIFFICULTIES AND A VESSEL DISSECTION OCCURRED. THE PHYSICIAN WAS ABLATING A LESION IN AN UNSPECIFIED VESSEL WITH A 1.25MM ROTABLATOR ROTALINK BUR. DURING REMOVAL OF THE BUR IN DYNAGLIDE MODE THE SYSTEM "COUGHED" AND BECAME INTERMITTENT CAUSING AN INABILITY TO REMOVE THE BUR. THE PHYSICIAN UNSUCCESSFULLY ATTEMPTED PRESSING AND CLUTCHING THE DYNAGLIDE FOOT PEDAL OF THE ROTABLATOR CONSOLE TO GET THE SYSTEM TO WORK. THE PHYSICIAN THEN "YANKED" THE BUR OUT OF THE VESSEL WITH DIFFICULTY AND A DISSECTION OCCURRED. THE PHYSICIAN DEPLOYED AN UNKNOWN STENT TO TREAT THE DISSECTION. PATIENT STATUS IS REPORTED AS "GREAT". ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310020

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention