BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INLAY OPTIMA MULTILENGTH URETERAL STENT

    MDR report key: 3252544 · Received July 25, 2013

    Report

    Report Number
    1018233-2013-02989
    Event Type
    Malfunction
    Date Received
    July 25, 2013
    Date of Event
    March 27, 2013
    Report Date
    May 29, 2013
    Manufacturer
    PRODUCTS PARA EL CUIDADO DELA SALUD
    Product Code
    FAD
    PMA / PMN Number
    K043193
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS NOT CONFIRMED. THE STENT WAS RECEIVED BROKEN IN TWO PIECES, BREAKING WHEN ATTEMPTING TO REMOVE THE GUIDEWIRE. DURING THE FUNCTIONAL EVALUATION OF THE RETURNED STENT, THE GUIDE WIRE ADVANCED OVER THE STENT WITHOUT ANY DIFFICULTY AND THE FAILURE COULD NOT BE DUPLICATED. THIS TEST WAS ALSO PERFORMED ON THE BROKEN PIGTAIL AND NO DISCREPANCIES WERE NOTICED. DIMENSIONS OF THE ID AND OD OF THE STENT WERE NOT TAKEN DUE TO STRESS MARKS ALONG THE SURFACE OF THE STENT AND PARTS DISPLAYED SLIGHT DEFORMATION. DIMENSIONS OF THE EYE PERFORATION WERE FOUND TO BE DEFORMED NEAR TO THE BREAKAGE SITE AND WERE FOUND TO BE OUT OF THE SPECIFICATIONS. THE DEFORMATION IS BELIEVED TO HAVE OCCURRED WHEN THE STENT WAS STRETCHED. DIRECTIONS FOR USE STATE: "DETERMINE THE PROPER STENT LENGTH FOR THE PATIENT. THIS IS GENERALLY CALCULATED FROM THE BASELINE PYELOGRAM. ACCURATE MEASUREMENTS WILL OPTIMIZE DRAINAGE EFFICIENCY AND PATIENT COMFORT. SUBMERGE STENT IN STERILE WATER TO ACTIVATE THE COATING. INSERT THE CYSTOSCOPE THEN PASS THE GUIDEWIRE THROUGH THE SCOPE UNTIL THE TIP IS IN THE RENAL PELVIS. MOVE THE PIGTAIL STRAIGHTENER OVER THE PROXIMAL END (KIDNEY COIL END) OF THE URETERAL STENT ALLOWING EASIER INSERTION ONTO THE GUIDEWIRE. REMOVE PIGTAIL STRAIGHTENER ONCE THE STENT IS SECURE ON THE GUIDEWIRE. PASS THE STENT OVER THE GUIDEWIRE THROUGH THE CYSTOSCOPE BY USING THE PUSH CATHETER FOR PROPER PLACEMENT. WATCH THE DISTAL END (BLADDER COIL END) OF THE STENT OR THE RADIOPAQUE, PROXIMAL END OF THE PUSHER. STOP ADVANCING WHEN THE STENT'S DISTAL END MARKER REACHES THE URETEROVESICAL JUNCTION (UVJ). (SEE BELOW FOR PROPER PLACEMENT DIRECTIONS ON THE MULTI-LENGTH URETERAL STENT). WITHDRAWAL THE GUIDEWIRE SLOWLY. THE STENT WILL FORM A PIGTAIL AUTOMATICALLY. CAREFULLY REMOVE THE PUSH CATHETER ACTIVATE THE GUIDEWIRE COATING ACCORDING TO THE "INSTRUCTIONS FOR USE" FOUND WITHIN THE GUIDEWIRE PACKAGING." (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT THE STENT DID NOT PROGRESS OVER THE GUIDEWIRE. THE STENT WAS BROKEN WHEN THEY ATTEMPTED TO REMOVE THE GUIDEWIRE. THERE WAS PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347995 INLAY OPTIMA MULTILENGTH URETERAL STENT FAD PRODUCTS PARA EL CUIDADO DELA SALUD NA NGTE0316

    Patients

    Seq Age Sex Outcome Treatment
    1