BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAY OPTIMA URETERAL STENT

    MDR report key: 2706936 · Received August 17, 2012

    Report

    Report Number
    1018233-2012-00965
    Event Type
    Malfunction
    Date Received
    August 17, 2012
    Date of Event
    July 5, 2012
    Report Date
    July 19, 2012
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD
    Product Code
    FAD
    PMA / PMN Number
    K043193
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE STENT NOTED HEAVY CALCIFICATION ALONG THE STENT. FUNCTIONAL TESTING WAS PERFORMED AND IT WAS FOUND THAT THE COATING ON THE OUTER SURFACE OF THE STENT WAS SUFFICIENT. THE SURFACE OF THE STENT WAS INSPECTED UNDER MAGNIFICATION FOR ANY CONDITION OR VISIBLE DEFECTS WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT AND NO DISCREPANCIES WERE OBSERVED. NO INCONSISTENCIES THAT COULD BE MFG RELATED WERE NOTED. THE LOT NUMBER WAS NOT PROVIDED THEREFORE THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE LABELING AND INSTRUCTIONS FOR USE WERE FOUND TO BE ADEQUATE: "URETERAL STENTS SHOULD BE CHECKED PERIODICALLY FOR SIGNS OF ENCRUSTATION AND PROPER FUNCTION. PERIODIC CHECKS OF THE STENT BY CYSTOSCOPIC AND/OR RADIOGRAPHIC PROCEDURES ARE RECOMMENDED AT INTERVALS DEEMED TO BE APPROPRIATE BY THE PHYSICIAN IN CONSIDERATION OF THE INDIVIDUAL PT'S CONDITION AND OTHER PT SPECIFIC FACTORS. WHEN LONG TERM USE IS INDICATED, IT IS RECOMMENDED THAT INDWELLING TIME NOT EXCEED 365 DAYS. THE STENT IS NOT INTENDED AS A PERMANENT INDWELLING DEVICE." (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED FOR FIVE MONTHS, THE SURFACE OF THE STENT CRYSTALLIZED AND HAD TO BE REMOVED VIA LASER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAY OPTIMA URETERAL STENT FAD PRODUCTOS PARA EL CUIDADO DE LA SALUD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention