BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INLAY URETERAL STENT

    MDR report key: 2833429 · Received October 26, 2012

    Report

    Report Number
    1018233-2012-01605
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 28, 2012
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD
    Product Code
    FAD
    PMA / PMN Number
    K983498
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RECEIVED WITHIN THE ORIGINAL PACKAGING AND THE STENT WAS BROKE OFF AT THE PIGTAIL ON THE BLADDER SIDE. VISUAL EXAMINATION WITH A MAGNIFIER NOTED THE BROKEN SECTION HAD STRESS MARKS AND JAGGED EDGES POSSIBLE INDICATING THAT THE STENT WAS STRESSED BEYOND ITS TENSILE CAPABILITIES. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE REPORTED LOT DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUED. THE LABELING AND INSTRUCTIONS FOR USE WERE FOUND TO BE ADEQUATE AND STATES THE FOLLOWING PRECAUTIONS: "DO NOT USE IF THE PACKAGE OR PRODUCT IS DAMAGED. EXERCISE CARE. TEARING OF THE STENT CAN BE CAUSED BY SHARP INSTRUMENTS. CARE SHOULD BE EXERCISED WHEN REMOVING THE STENT FROM INNER POLYBAG SO AS NOT TO CAUSE TEARING OR FRAGMENTATION." (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENT INSERTION PROCEDURE, THE GUIDEWIRE WAS STUCK WITHIN THE STENT. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NOT IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INLAY URETERAL STENT FAD PRODUCTOS PARA EL CUIDADO DE LA SALUD NA NGWC2336

    Patients

    Seq Age Sex Outcome Treatment
    1