BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROTALINK¿ PLUS

    MDR report key: 6196607 · Received December 21, 2016

    Report

    Report Number
    2134265-2016-11336
    Event Type
    Death
    Date Received
    December 21, 2016
    Date of Event
    November 18, 2016
    Report Date
    November 21, 2016
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    UDI-DI
    08714729228363
    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: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. 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 MDR ID: 2134265-2016-11337, 2134265-2016-11338, 2134265-2016-11339, 2134265-2016-11340, 2134265-2016-11343, 2134265-2016-11355, 2134265-2016-11341, 2134265-2016-11342, 2134265-2016-11380, 2134265-2016-11378, 2134265-2016-11379. 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
    843579 ROTALINK¿ PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310030 19842632 08714729228363

    Patients

    Seq Age Sex Outcome Treatment
    1 Death CONSOLE: ROTA CONSOLE| DYNAGLIDE FOOT PEDAL| GUIDE WIRE: ROTAWIRE