BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 2173089 · Received July 23, 2011

    Report

    Report Number
    2134265-2011-02728
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RECEIVED IN TWO PIECES. THE COREWIRE WAS FOUND TO BE FRACTURED AT 199.7CM FROM THE PROXIMAL END. THE SEM INSPECTION FOUND THAT "THE FAILURE IN BOTH SAMPLES WAS DUE TO A WEAR REDUCTION OF THE CROSS-SECTIONAL AREA AND EDS ANALYSIS SHOWS EVIDENCE OF COPPER OVER THE WEAR SURFACE". THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE A GUIDE WIRE FRACTURE OCCURRED. DURING PREFORMING, OUTSIDE THE PATIENT, THE 330CM ROTAWIRE GUIDE WIRE FRACTURED. THE ROTAWIRE WAS PULLED HOWEVER THEY WERE UNABLE TO REWIRE THE LESION. THE CASE WAS NOT COMPLETED DUE TO THIS EVENT, BUT WAS RESCHEDULED FOR A LATER DATE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE A GUIDE WIRE FRACTURE OCCURRED. DURING PLATFORMING, OUTSIDE THE PATIENT, THE 330CM ROTAWIRE GUIDE WIRE FRACTURED. THE ROTAWIRE WAS PULLED HOWEVER, THEY WERE UNABLE TO REWIRE THE LESION. THE CASE WAS NOT COMPLETED DUE TO THIS EVENT, BUT WAS RESCHEDULED FOR A LATER DATE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - COSTA RICA H802228240020 14095399

    Patients

    Seq Age Sex Outcome Treatment
    1