BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCX CATHETER, CORONARY, ATHERECTOMY

    MDR report key: 1082637 · Received July 23, 2008

    Report

    Report Number
    2134265-2008-02040
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Report Date
    June 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE HISTORICAL TRENDING AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME EVENT AS MFR REPORT#: 2134265-2008-02041. IT WAS REPORTED THAT DURING AN PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE WITH ATHERECTOMY, BURR WITHDRAWAL DIFFICULTIES WERE ENCOUNTERED. THE LESION BEING TREATED WAS A HEAVILY CALCIFIED LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE BURR STUCK IN THE LESION, AND THE PHYSICIAN WAS UNABLE TO REMOVE THE BURR IN THE DYNAGLIDE MODE. THEREFORE HE REMOVED THE BURR MANUALLY. IT WAS ALSO REPORTED THAT THERE WAS SOME TRAUMA TO THE TARGET VESSEL, BUT THE PT RECOVERED FROM THE INCIDENT. IT WAS NOT KNOWN IF THIS WAS RELATED TO THE PRODUCT OR IF IT WAS A RESULT OF THE VESSEL TORTUOSITY OR LESION MORPHOLOGY. THE PT STATUS WAS REPORTED AS STABLE. NO FURTHER INFO WILL BE PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other