BEUDAMED
    FDA Adverse Event Summary report: N

    SCEPTER XC

    MDR report key: 3242378 · Received June 6, 2013

    Report

    Report Number
    3242378
    Date Received
    June 6, 2013
    Date of Event
    March 22, 2013
    Report Date
    June 6, 2013
    Manufacturer
    MICROVENTION, INC.
    Product Code
    MJN
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    FIVE MINUTES AFTER THE CONCLUSION OF A TRANSFEMORAL CEREBRAL ANGIOGRAPHY, WITH A 40-MINUTE LEFT INTERNAL CAROTID ARTERY BALLOON TEST OCCLUSION, THE PATIENT EXPERIENCED SLURRED SPEECH, RIGHT FACIAL DROOP, AND RIGHT ARM WEAKNESS THAT LASTED FOR 35 MINUTES. THIS RESOLVED AND THE PATIENT WAS MONITORED CLOSELY IN THE ICU (APPROPRIATE TREATMENT RENDERED OVERNIGHT). A SUBSEQUENT CT SCAN COMPLETED MINUTES AFTER THE SYMPTOMS APPEARED SHOWED INTERVAL APPEARANCE OF AIR WITHIN THE TARGETED AREA OF THE INTERNAL CAROTID ARTERY ANEURYSM. THE AIR DISSIPATED ON SUBSEQUENT CT SCANS AND THE PATIENT WAS DISCHARGED TO HOME WITH HER HUSBAND WITHOUT NEED FOR ADDITIONAL SERVICES AS A RESULT OF THIS EVENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?INTENDED PROCEDURE WAS A TRANSFEMORAL CEREBRAL ANGIOGRAPHY, WITH LEFT INTERNAL CAROTID ARTERY BALLOON TEST OCCLUSION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252142 SCEPTER XC CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY MJN MICROVENTION, INC. * 12090534

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR BALLOON CATHETER, SCEPTER XC BALLOON CATHETER.| NO OTHER THERAPIES| GLIDE WIRE, TERUMO EXCHANGE LENGTH GLIDE WIRE,| DURING THE INTERVENTIONAL PROCEDURE, THE FOLLOWING| DAVIS GUIDE DIAGNOSTIC CATHETER, CONCENTRIC| MATERIALS WERE USED: 9 FR PINNACLE SHEATH, TERUMO