BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUFLEX PLUS URETERAL STENT

    MDR report key: 1326017 · Received February 26, 2009

    Report

    Report Number
    3005099803-2008-04039
    Event Type
    Malfunction
    Date Received
    February 26, 2009
    Date of Event
    February 14, 2007
    Report Date
    February 19, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION-SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K924608
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED BY THIS MANUFACTURER. AN EVALUATION HAS NOT BEEN PERFORMED; THEREFORE A FAILURE ANALYSIS IS NOT AVAILABLE. PRODUCT UNAVAILABLE FOR ANALYSIS.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO DEVICES THAT WERE USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 6000043-2007-00027 FOR A DESCRIPTION OF THE FIRST DEVICE. THE ENDOPROSTHESIS SEEMS TO HAVE A MANUFACTURING DEFECT: ABNORMAL DISTAL END APPEARED TO BE CRUSHED AND THE PROSTHESIS WOULD MIGRATE AFTER ITS CORRECT PLACEMENT IN THE KIDNEY. THREE DEVICES WERE USED (NECESSARY) FOR ONE PROCEDURE. THE PATIENT DID NOT SUSTAIN ANY ADVERSE EFFECT OR COMPLICATION AS A RESULT OF THIS ISSUE. THE PATIENT CONDITION IS REPORTED AS 'OK' AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUFLEX PLUS URETERAL STENT FGE FGE BOSTON SCIENTIFIC CORPORATION-SPENCER M006175273030 0009316556

    Patients

    Seq Age Sex Outcome Treatment
    1