BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 3770888 · Received April 24, 2014

    Report

    Report Number
    2134265-2014-02170
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 28, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    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

    SAME CASE AS MDR ID 2134265-2014-02171. IT WAS REPORTED THAT THE ROTAWIRE SEPARATED. A 1.25MM ROTALINK PLUS AND ROTAWIRE FLOPPY WAS SELECTED TO TREAT THE TARGET LESION. DURING PLATFORMING OUTSIDE OF THE PATIENT, WHEN PHYSICIAN TRIED TO SET RPM, IT WAS NOTED THAT THE BURR CUT THE ROTAWIRE IN TWO PARTS. PROCEDURE WAS COMPLETED WITHOUT ROTABLATOR. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248462 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - COSTA RICA (COYOL) UNK509

    Patients

    Seq Age Sex Outcome Treatment
    1