BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICAST

    MDR report key: 1961528 · Received December 16, 2010

    Report

    Report Number
    1961528
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 15, 2010
    Manufacturer
    ATRIUM MEDICAL CORP
    Product Code
    JCT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ICAST BALLOON MOUNTED STENT WAS INFLATED IN THE PATIENT'S LEFT ILIAC ARTERY. BALLOON FAILED TO DEFLATE, GOT CAUGHT IN THE STRUTS OF THE STENT AND RUPTURED. PHYSICIAN WAS UNABLE TO REMOVE THE BALLOON CATHETER. SURGICAL CUT DOWN OF THE LEFT GROIN WAS NECESSARY TO REMOVE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICAST COVERED STENT JCT ATRIUM MEDICAL CORP 9 MM X 59 MM X 120 CM 106107523

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR