BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICAST

    MDR report key: 2894388 · Received November 30, 2012

    Report

    Report Number
    1219977-2012-00030
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    October 12, 2012
    Report Date
    November 5, 2012
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    JCT
    PMA / PMN Number
    K050814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS, INCLUDING THE CRIMPING PROCESS, INDICATED THAT THE ICAST DEVICE WAS PROCESSED AND INSPECTED ACCORDING TO SPECIFICATIONS AND NO NON-CONFORMITIES WERE FOUND. ATRIUM MEDICAL'S QUALITY CONTROL DEPARTMENT INSPECTS 20% OF EACH PRODUCTION LOT PRODUCED TO INCLUDE PASSAGE OF THE DEVICE THROUGH THE APPROPRIATE SIZE INTRODUCER IN ORDER TO ASSESS THAT THE CRIMPING PROCESS HAS PROPERLY SECURED THE STENT TO THE BALLOON. DEVICE WAS NOT RETURNED, THEREFORE, AN EVALUATION WAS NOT PERFORMED AND NO CONCLUSION CAN BE DRAWN. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OR ANY RELEVANT ADDITIONAL INFORMATION THAT IS OBTAINED.

    Description of Event or Problem · 1

    ICAST STENT SLID OFF OF BALLOON. PHYSICIAN TRIED TO GET IT BACK USING SEVERAL DEVICES BUT COULD NOT. HAD TO PLACE AND DEPLOY IT DISTALLY TO INTENDED AREA. ANGIOPLASTIED INTENDED PLACE INSTEAD. PHYSICIAN STATES THIS HAS HAPPENED BEFORE WITH HIM AND PARTNERS. HE SAYS THE CLOTH MATERIAL CAN GET STUCK/HUNG UP ON CALCIFICATIONS OR PREVIOUS STENT STRUTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICAST JCT ATRIUM MEDICAL CORPORATION 85452 10739603

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other