BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICAST

    MDR report key: 2497904 · Received March 13, 2012

    Report

    Report Number
    1219977-2012-00006
    Event Type
    Other
    Date Received
    March 13, 2012
    Date of Event
    January 18, 2012
    Report Date
    March 13, 2012
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    JCT
    PMA / PMN Number
    K050814
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED. THE DEVICE MET SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE INITIAL REPORTER HAS BEEN CONTACTED TO REQUEST THE RETURN OF THE DEVICE FOR EVALUATION.

    Description of Event or Problem · 1

    EVENT DESC: MD WAS PERFORMING AN ANGIOGRAM ON PATIENT'S LEFT LEG AND LOCATED A LESION WITH ASSOCIATED THROMBUS IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A DECISION WAS MADE TO DEPLOY A STENT. AS STENT WAS BEING ADVANCED IN THE SFA, IT WAS MOVED PAST THE LESION WITHOUT DIFFICULTY. WHEN THE MD ATTEMPTED TO COME BACK AROUND THE LESION WITH THE BALLOON STENT, THE STENT UNINTENTIONALLY SEPARATED FROM THE BALLOON (IT WAS NOT DEPLOYED). ONE IT BROKE AWAY FROM THE DEPLOYMENT SYSTEM THE STENT WAS FREE FLOATING IN THE ARTERY. MD ATTEMPTED TO RETRIEVE SEVERAL TIMES, BUT WAS UNABLE TO DO SO. PATIENT WAS THEN MOVED TO THE OPERATING ROOM FOR AN EMERGENCY OPEN PROCEDURE TO REMOVE THE STENT. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICAST STENT, 5MMX38MMX120CM JCT ATRIUM MEDICAL CORP. 85410 10670925

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other