BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 4280507 · Received November 21, 2014

    Report

    Report Number
    MW5039270
    Event Type
    Injury
    Date Received
    November 21, 2014
    Date of Event
    November 1, 2014
    Report Date
    November 4, 2014
    Manufacturer
    BUSINESS & TECHNOLOGY PARK
    Product Code
    MCW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ROTABLATER BURR DISENGAGED FROM CATHETER DURING USE BUT WAS CAPTURED BY LARGER DIAMETER TIP ROTAWIRE UPON WIRE REMOVAL. REASON FOR USE: CALCIFIED ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757155 BOSTON SCIENTIFIC ROTALINK BURR 1.5MM MCW BUSINESS & TECHNOLOGY PARK H802227680030 17017432

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other