BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 4151755 · Received October 8, 2014

    Report

    Report Number
    2134265-2014-06077
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    September 12, 2014
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RPM WAS NOT DISPLAYED. A ROTABLATOR CONSOLE WAS USED FOR TREATMENT. DURING PROCEDURE, IT WAS NOTED THAT THE ROTATIONAL SPEED WAS NOT DISPLAYED PROPERLY. THE PHYSICIAN FELT THAT THE LESION WAS BEING ABLATED BUT THE ROTATIONAL SPEED DISPLAYED WOULD NOT CHANGE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633452 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - FREMONT (CE) H802220200391 RC108102

    Patients

    Seq Age Sex Outcome Treatment
    1