BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCEPTER XC

    MDR report key: 2820192 · Received September 23, 2012

    Report

    Report Number
    2820192
    Event Type
    Injury
    Date Received
    September 23, 2012
    Date of Event
    August 20, 2012
    Report Date
    September 20, 2012
    Manufacturer
    MICROVENTION INC, A TERUMO COMPANY
    Product Code
    MJN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD SYMPTOMATIC ANTERIOR COMMUNICATING ANEURYSM AND UNDERWENT COIL EMBOLIZATION WITH POSSIBLE STENTING. DURING THE PROCEDURE THE BALLOON RUPTURED A VESSEL AND THE PATIENT EXPERIENCED AN ACUTE INTRACRANIAL BLEED WITH LARGE HEMORRHAGIC STROKE. VENTRIC WAS INSERTED DURING THE PROCEDURE. THE PATIENT IS CURRENTLY IN THE ICU. THE PHYSICIAN STATES WHEN THE BALLOON INFLATED IT FELT VERY "WEIRD". THE BALLOON WAS RETURNED TO THE VENDOR REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCEPTER XC CATHETER, INTRAVASCULAR, OCCLUDING, TEMPORARY MJN MICROVENTION INC, A TERUMO COMPANY BC0411XC *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R