BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICAST

    MDR report key: 2052130 · Received March 18, 2011

    Report

    Report Number
    2052130
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 18, 2011
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    JCT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING A VENOGRAPHY AND STENT PLACEMENT AND THE BALLOON DETACHED FROM THE CATHETER SHAFT DURING REMOVAL FROM THE SHEATH. BALLOON LODGED IN THE SHEATH BUT WAS EASILY REMOVED WITH THE WIRE POSITION MAINTAINED. A NEW SHEATH WAS INSERTED AND THE CASE WAS COMPLETED WITHOUT FURTHER EVENT. CATH CATHETERIZATION LAB STAFF NOTED THAT THE BALLOON BROKE WHEN PRESSURE WAS APPLIED.======================MANUFACTURER RESPONSE FOR COVERED STENT, ICAST======================MANUFACTURER WANTS THE DEVICE RETURNED SO THAT THEY CAN EVALUATE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICAST COVERED STENT JCT ATRIUM MEDICAL CORPORATION * 1045928309

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR