BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.6F22-30CM SILHOUETTE COMFORT MULTI-LENGTH UPD

    MDR report key: 3243193 · Received July 19, 2013

    Report

    Report Number
    2027111-2013-00283
    Event Type
    Malfunction
    Date Received
    July 19, 2013
    Date of Event
    June 20, 2013
    Report Date
    January 6, 2014
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FAD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE ANTICIPATED TO RETURN. A F/U REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE EVENT UNIT WAS RETURNED FOR EVALUATION. UPON INSPECTION, ENGINEERING FOUND THAT THE STENT HAD ENCRUSTATION ON THE OUTSIDE AND A KNOT AT THE PROXIMAL END. THE SUTURE WAS MISSING FROM THE DISTAL END. THE UNIT PRESENTED MINIMAL ENCRUSTATION ON THE INSIDE LUMEN.ENGINEERING DETERMINED THAT THE ROOT CAUSE FOR THE ENCRUSTATION MAY BE ATTRIBUTED TO PATIENT PHYSIOLOGY. THE MATERIALS OF THE SILHOUETTE STENT ARE NOT KNOWN TO PROMOTE ENCRUSTATION AS THE DEVICE HAS BEEN TESTED FOR BIOCOMPATIBILITY AS AN IMPLANT.THIS DOCUMENT REPRESENTS OUR FINAL REPORT.

    Description of Event or Problem · 1

    STENT REMOVAL - "ON REMOVAL THE STENT WOULDN'T RELEASE FROM THE KIDNEY. ON XRAY IT WAS NOTED THAT THE STENT WAS ENCRUSTED AND KNOTTED IN THE KIDNEY. A FLEXIBLE SCOPE WAS USED TO ASSIST THE STENT BEING REMOVED AND THE ENCRUSTATION REQUIRED TO BE BROKEN UP BY LASER." PATIENT STATUS: "OKAY".

    Description of Event or Problem · 1

    STENT REMOVAL - "ON REMOVAL THE STENT WOULD RELEASE FROM THE KIDNEY. ON XRAY IT WAS NOTED THAT THE STENT WAS ENCRUSTED AND KNOTTED IN THE KIDNEY. A FLEXIBLE SCOPE WAS USED TO ASSIST THE STENT BEING REMOVED AND THE ENCRUSTATION REQUIRED TO BE BROKEN UP BY LASER. PT STATUS: "OKAY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338051 4.6F22-30CM SILHOUETTE COMFORT MULTI-LENGTH UPD POLYMERIC URETERAL STENT, CODE:FAD FAD APPLIED MEDICAL B3827 1181454

    Patients

    Seq Age Sex Outcome Treatment
    1 Other FLEXIBLE URETERSCOPE LASER