BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INLAY OPTIMA URETERAL STENT

    MDR report key: 3061592 · Received April 11, 2013

    Report

    Report Number
    1018233-2013-01289
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    January 28, 2013
    Report Date
    March 14, 2013
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD
    Product Code
    FAD
    PMA / PMN Number
    K043193
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE FINISHED PRODUCT MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED FOR GENERAL DISTRIBUTION. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. THE INSTRUCTIONS FOR USE STATES IN THE PRECAUTIONS: "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 PATIENT'S CONDITION AND OTHER PATIENT 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 THE STENTS COULD NOT BE REMOVED DUE TO CRYSTALLIZATION. THE PATIENT HAD STENTS PLACED IN BOTH URETERS DUE TO SEVERE PAIN CAUSED BY URINARY STONES, 3 DAYS BEFORE GIVING BIRTH. AFTER MORE THAN 40 DAYS, REMOVAL OF THE STENTS WAS ATTEMPTED AFTER THE PATIENT COMPLAINED OF UNBEARABLE PAIN. THE STENTS WERE UNABLE TO BE REMOVED BY STANDARD METHODS DUE TO CRYSTALLIZATION ON THE SURFACE OF THE STENTS. THE DOCTOR USED A HOLMIUM LASER TO BREAK APART THE STONES, AND WAS ABLE TO REMOVE THE STENTS. VARYING DEGREES OF CRYSTALLIZATION WAS FOUND ON THE SURFACES OF BOTH STENTS. FOLLOWING THE SURGERY, THE PATIENT'S CONDITION WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156788 INLAY OPTIMA URETERAL STENT FAD PRODUCTOS PARA EL CUIDADO DE LA SALUD NA NGVI1658

    Patients

    Seq Age Sex Outcome Treatment
    1