BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCEPTER OCCLUSION BALLOON CATHETER

    MDR report key: 3181566 · Received June 17, 2013

    Report

    Report Number
    2032493-2013-00035
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    March 22, 2013
    Report Date
    May 28, 2013
    Manufacturer
    MICROVENTION, INC.
    Product Code
    MJN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE ANALYSIS: AN EVAL OF THE ACTUAL COMPLAINT SAMPLE HAS NOT BEEN PERFORMED AS IT WAS DISCARDED BY THE USER CENTER. THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED. NO ABNORMAL DISCREPANCIES OR NON-CONFORMANCES WERE OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WITH A HISTORY OF HYPERTENSION AND A LICA GIANT ANEURYSM UNDERWENT BALLOON TEST OCCLUSION. AFTER 5 MINUTES A CHANGE IN NEUROLOGICAL STATUS WAS OBSERVED. DURING A SCAN AIR WAS OBSERVED. THE PT WAS ADMITTED TO THE ICU AND THE FOLLOWING DAY SHOWED RESOLUTION OF AIR. THE PT WAS DISCHARGED ON (B)(6) 2013. THE PT WAS REPORTED TO BE FINE. NO HARM OR INJURY WAS ENCOUNTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273993 SCEPTER OCCLUSION BALLOON CATHETER BALLOON CATHETER MJN MICROVENTION, INC. BC0411XC 12090534

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization