BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 3073177 · Received April 23, 2013

    Report

    Report Number
    2134265-2013-02521
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    March 25, 2013
    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 MANUFACTURER: 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 DURING PREPARATION FOR A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, UNSTABLE SPEED OCCURRED. THE SPEED ON THE ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WAS UNSTABLE DURING TEST. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173632 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - FREMONT (CE) H802220200391 RC107159

    Patients

    Seq Age Sex Outcome Treatment
    1