BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 3813130 · Received May 15, 2014

    Report

    Report Number
    2134265-2014-02606
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    January 3, 2014
    Report Date
    April 18, 2014
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: EXAMINATION OF THE RETURNED COMPLAINT DEVICE REVEALED THAT THE ROTATIONAL SPEED WAS NOT DISPLAYED IN TURBINE OR DYNAGLIDE MODES, ALTHOUGH THE BURR IS ROTATING. THERE IS A GAS/AIR LEAK FROM THE TURBINE PRESSURE SWITCH. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. GIVEN THE AGE OF THE CONSOLE, THE MOST LIKELY ROOT CAUSE FOR THE REPORTED DIFFICULTIES IS DUE TO NORMAL WEAR AND TEAR. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT DURING PREPARATION FOR A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, THE ROTABLATOR SYSTEM IS LOOSING PRESSURE. THIS ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WAS SELECTED; HOWEVER, DURING PREPARATION IT WAS REPORTED THAT THE ROTABLATOR SYSTEM WAS LOOSING PRESSURE DURING THE INTERVENTION. IT WAS NOTED THAT THE PRESSURE IS LOST AFTER REACHING THE CONSOLE, SO THERE IS NOT ENOUGH PRESSURE GOING TO THE FOOT PEDAL. NO PATIENT COMPLICATIONS WERE REPORTED THE PATIENT'S STATUS IS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE ROTATIONAL SPEED WAS NOT DISPLAYED IN TURBINE OR DYNAGLIDE MODES, ALTHOUGH THE BURR IS ROTATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290449 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - FREMONT (CE) H802220200361

    Patients

    Seq Age Sex Outcome Treatment
    1