BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMERGE MONORAIL

    MDR report key: 3866735 · Received June 4, 2014

    Report

    Report Number
    MW5036510
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    January 18, 2014
    Report Date
    May 30, 2014
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A CEREBRAL ARTERIOGRAM AND BASILAR ARTERY ENDOVASCULAR ANGIOPLASTY WITH STENT AND IA TPA FOR A BASILAR ARTERY STROKE IN LIGHT OF HIGH GRADE BASILAR ARTERY STENOSIS. A BOSTON SCIENTIFIC EMERGE MONORAIL 3.0 MM X 20 MM BALLOON DELIVERY SYSTEM AND NEUROSCOUT 0.014 INCH MICROWIRE CONSTRUCT WAS INSERTED INTO THE SCA. THE GUIDE CATHETER WAS THEN ADVANCED TO THE LEFT VERTEBRAL ARTERY UNDER FLUOROSCOPIC GUIDANCE. THE MICROWIRE WAS POSITIONED TO THE RIGHT SCA VESSEL. THE BALLOON WAS ADVANCED TO THE LEVEL OF THE AREA OF MAXIMAL STENOSIS WITHIN THE BASILAR ARTERY. THE BALLOON WAS INFLATED TO NOMINAL PRESSURE. THE BALLOON WAS DEFLATED. ATTEMPTS TO RETRACT THE MICROWIRE FROM THE RIGHT SCA WERE MET WITH RESISTANCE. FLUOROSCOPIC IMAGING IDENTIFIES THE PRESENCE OF THE MICROWIRE SNAGGED WITHIN THE RIGHT SCA. MULTIPLE MANEUVERS WERE PERFORMED IN AN ATTEMPT TO DISLODGE THE MICROWIRE FROM THE RIGHT SCA. AFTER A SIGNIFICANT AMOUNT OF TIME ENGAGING IN MULTIPLE MANEUVERS TO DISLODGE THIS MICROWIRE. THE MICROWIRE WAS THEN PLACED UNDER TENSION WHICH RESULTED IN INTENTIONAL FRACTURE OF THE MICROWIRE. THIS FRACTURED MICROWIRE AND BALLOON DELIVERY SYSTEM WAS THEN RETRIEVED FROM THE SHUTTLE SHEATH OVER THE GUIDE CATHETER. ADD'L ANGIOGRAPHIC IMAGING IDENTIFIED REOCCLUSION OF THE BASILAR ARTERY. THE BOSTON SCIENTIFIC EMERGE MONORAIL 3.0 MM X 20 MM BALLOON DELIVERY SYSTEM AND A NEW 0.014 INCH MICROWIRE CONSTRUCT WERE INSERTED WITH THE GUIDE CATHETER ADVANCED INTO THE LEFT VERTEBRAL ARTERY UNDER FLUOROSCOPIC GUIDANCE. REASON FOR USE: BASILAR ARTERY STROKE IN LIGHT OF HIGH-GRADE BASILAR ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327215 EMERGE MONORAIL BALLOON DELIVERY SYSTEM, 3.0 MM X 20 MM LIT BOSTON SCIENTIFIC

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization CRESTOR 10 MG DAILY.| CIALIS 20 MG Q.36 HOURS P.R.N.| ZETIA 10 MG DAILY.| ASPIRIN 81 MG DAILY.| VITAMIN B COMPLEX DAILY.| VIAGRA 100 MG DAILY P.R.N.| LISINOPRIL 40 MG DAILY.