BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INLAY OPTIMA URETERAL STENT

    MDR report key: 2133502 · Received June 15, 2011

    Report

    Report Number
    1018233-2011-00135
    Event Type
    Injury
    Date Received
    June 15, 2011
    Report Date
    September 30, 2011
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FAD
    PMA / PMN Number
    K043193
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. IN ADDITION, THE MANUFACTURING PROCESS FOR THIS PRODUCT CODE SHOWED THAT THIS STENT IS RECEIVED FROM A SUPPLIER WHO PROVIDES CERTIFICATION THAT THE STENT HAS BEEN MANUFACTURED, INSPECTED, AND ACCEPTED ACCORDING TO THE SPECIFICATIONS PROVIDED BY THE MANUFACTURER. AS A FINISHED GOOD, QUALITY ASSURANCE PERFORMS RANDOM VISUAL INSPECTIONS TO ASSURE THAT ALL COMPONENTS ARE PRESENT AND CORRECT. A REVIEW OF INTERNAL REJECT RECORDS SHOWED NO REJECTIONS RESULTED FROM THE VISUAL INSPECTIONS OVER THE LAST TWO YEARS. THE INSTRUCTIONS FOR USE STATES IN THE PRECAUTIONS SECTION THE FOLLOWING RELATED TO PROPER USE OF STENTS: "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 A PATIENT BEGAN COMPLAINING OF PAIN 4 WEEKS AFTER STENT PLACEMENT. DURING REMOVAL WITH STENT GRASPERS, THE STENT WAS DIFFICULT TO REMOVE DUE TO TISSUE GROWTH WITHIN THE STENT. AFTER REMOVAL, A RETROGRADE URETEROGRAPHY WAS PERFORMED WHICH REVEALED LEAKAGE FROM THE URETER. A NEPHROSTOMY WAS PLACED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INLAY OPTIMA URETERAL STENT FAD C.R. BARD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention