BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 2041320 · Received April 6, 2011

    Report

    Report Number
    2134265-2011-01260
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Report Date
    March 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN; THEREFORE THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL AND/OR PROCEDURAL FACTORS. (B)(4)

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2011-01261. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, THE BURR BECAME STUCK. THE OPERATOR SAID THAT THE BURR BECAME STUCK UPON RETRIEVAL AND THOUGHT THIS WAS THE FAULT OF THE FOOT PEDAL. NO PATIENT COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK UNK553

    Patients

    Seq Age Sex Outcome Treatment
    1