BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 4111357 · Received September 23, 2014

    Report

    Report Number
    2134265-2014-05633
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    May 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND 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 PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2014-05641. REPORTABLE BASED ON RELATED DEVICE ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT THE BURR BECAME STUCK ON THE WIRE. A 1.50MM ROTALINK¿ PLUS AND A ROTAWIRE WERE SELECTED AND ADVANCED TO TREAT THE TARGET LESION. ROTABLATION WITH MULTIPLE PASSES WAS SUCCESSFUL. DURING WITHDRAWAL, WHILE USING DYNAGLIDE, THEY HAD DIFFICULTY REMOVING THE SYSTEM. THE BURR CATHETER BECAME STUCK ON THE WIRE. THEY WERE ABLE TO REMOVE THE SYSTEM WITH A FLUSH ON UNDER FLOW TECHNIQUE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS FINE. HOWEVER, ANALYSIS OF THE RELATED DEVICE REVEALED A WIRE FRAGMENT IN THE ANNULUS OF THE BURR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589520 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - COSTA RICA (COYOL) UNK509

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR