BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUFLEX URETERAL STENT

    MDR report key: 728122 · Received June 15, 2006

    Report

    Report Number
    6000043-2006-00070
    Event Type
    Malfunction
    Date Received
    June 15, 2006
    Date of Event
    February 6, 2006
    Report Date
    May 23, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE STENT AND POSITIONER (PUSHER) WAS RECEIVED WITH THE ORIGINAL POUCH, IN A ZIPLOC BAG A VISUAL AND FUNCTIONAL EVALUATION REVEALED A CUT/TEAR IN THE STENT APPROXIMAELY 10 CM FROM THE DISTAL END. THE TEAR DID NOT RESEMBLE THAT OF A SUTURE CUT. THE FAILURE MODE WAS REPRODUCED BY PULLING THE STENT APART WITH EXCESSIVE FORCE. A DIMENSIONAL CHECK WAS NOT PERFORMED. A LOT HISTORY SEARCH WAS PERFORMED AND REVEALED NO OTHER COMPLAINTS AGAINST LOT #7993357 FOR THIS FAILURE MODE. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ANOMALIES. THE INITIAL CUSTOMER COMPLAINT WAS NOT CONFIRMED, AS THE POSITIONER (PUSHER) WAS RETURNED WITH THE PRODUCT. DUE TO THE NATURE OF THE TEAR, IT IS BELIEVED THAT DURING PREPARATION, THE STENT WAS PULLED APART USING EXCESSIVE FORCE. THE ROOT CAUSE IS BELIEVED TO BE USER ERROR.

    Description of Event or Problem · 1

    DURING UNPACKING OF A PERCUFLEX PLUS URETERAL STENT, THERE WAS NO PUSHER PACKAGED WITH THE PRODUCT. AS THE MALFUNCTION OCCURRED DURING PREPARATION, THERE WERE NO PATIENT INJURIES OR COMPLICATIONS INVOLVED AND THE PROCEDURE WAS SUCCESFULLY COMPLETED WITH ANOTHER DEVICE. BASED ON THE ENGINEERING EVALUATION OF THE DEVICE, THE STENT WAS DISCOVERED TO HAVE A COMPLETER TEAR APPROXIMATELY 10 CM FROM THE DISTAL END. THE PUSHER WAS PACKAGED WITH THE STENT UPON RETURN, BUT THE STRAIGHTENER WAS NOT. IT IS LIKELY THAT THE USER FACILITY WAS REFERRING TO THE STRAIGHTETER, RATHER THAN THE PUSHER, IN THE INITIAL COMPLAINT REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUFLEX URETERAL STENT PERCUFLEX URETERAL STENT FAD BOSTON SCIENTIFIC NA 7993357

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN