BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 6196573 · Received December 21, 2016

    Report

    Report Number
    2134265-2016-11379
    Event Type
    Death
    Date Received
    December 21, 2016
    Date of Event
    November 21, 2016
    Report Date
    November 21, 2016
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. 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: 2134265-2016-11337; 2134265-2016-11338; 2134265-2016-11355; 2134265-2016-11341; 2134265-2016-11342; 2134265-2016-11339; 134265-2016-11340; 2134265-2016-11343; 2134265-2016-11380; 2134265-2016-11378; 2134265-2016-11336. IT WAS REPORTED THAT PATIENT DEATH OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. DURING TESTING OF A 1.50MM ROTALINK¿ PLUS AND ROTAWIRE GUIDE WIRE WITH THE ROTABLATOR CONSOLE AND A DYNAGLIDE FOOT PEDAL, THE SYSTEM BASELINE TESTED "OKAY" OUTSIDE THE PATIENT. ROTATIONAL ATHERECTOMY WAS PERFORMED HOWEVER, THE BURR STOPPED SPINNING AND A HISSING NOISE WAS NOTED FROM THE NITROGEN TANK TO THE CONSOLE. IT WAS FURTHER REPORTED ATHERECTOMY WAS DISCONTINUED AND SEVERAL BOSTON SCIENTIFIC BALLOONS AND STENTS WERE UTILIZED. THE PATIENT EXPIRED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843252 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - FREMONT (CE) H802220200291

    Patients

    Seq Age Sex Outcome Treatment
    1 Death 1.50MM ROTALINK¿ PLUS| GUIDE WIRE: ROTAWIRE| ROTA CONSOLE