BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICAST COVERED STENT

    MDR report key: 3894006 · Received June 10, 2014

    Report

    Report Number
    1219977-2014-00179
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    JCT
    PMA / PMN Number
    K050814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE IN THE PROCESS OF PERFORMING THE INVESTIGATION AND WILL SUBMIT THE FOLLOW-UP REPORT ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    REPORT WAS RECEIVED THAT A STENT WAS DEPLOYED. THE BALLOON WAS DEFLATED AND IT WAS ATTEMPTED TO REMOVE THE CATHETER FROM A TERUMO GLIDEWIRE ADVANTAGE .035" OUT OF A 7FR 10CM TERUMO PINNACLE SHEATH. THE PHYSICIAN AND THE TECH EXPERIENCED RESISTANCE BACKING THE CATHETER OFF BUT THEY CONTINUED TO PULL OUT THE CATHETER. THE BALLOON BROKE OFF INTO THE SHEAT AND THE PHYSICIAN HAD TO GET A SECOND ACCESS IN THE PATIENT TO CONTINUE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343383 ICAST COVERED STENT COVERED STENT JCT ATRIUM MEDICAL CORPORATION 85424 206923

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention BOSTON SCIENTIFIC XXL DILATION BALLOON - 14MM| TERUMO GLIDEWIRE ADVANTAGE - 0.035 X 260CM| TERUMO INTRODUCER SHEATH - 7FR X 10CM