BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUFLEX URETERAL STENT

    MDR report key: 1171421 · Received September 17, 2008

    Report

    Report Number
    3005099803-2008-04642
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Report Date
    August 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K834468
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE PERCUFLEX URETERAL STENT LOT WAS PERFORMED; NO ANOMALIES WERE NOTED. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND NO OTHER COMPLAINTS AGAINST LOT NUMBER 9378523. THE 2008 PERCUFLEX W/O WIRE PRODUCT FAMILY TRENDING CHART WAS REVIEWED AND DOES NOT SHOW A NEGATIVE TREND.

    Description of Event or Problem · 1

    NOTE: THE DATE OF THE EVENT IS UNK. IT WAS REPORTED TO BOSTON SCIENTIFIC CORP IN 2008, THAT A PERCUFLEX URETERAL STENT WAS USED DURING A URETEROSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, THE STENT BROKE AS THEY WERE PUTTING IT INTO THE PATIENT. THE NURSE STATED "IT WAS LIKE IT RIPPED APART". THEY WERE ABLE TO RETRIEVE IT FROM THE PT BECAUSE IT STAYED ON THE WIRE. PROCEDURE COMPLETED WITH ANOTHER PERCUFLEX URETERAL STENT. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION WAS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUFLEX URETERAL STENT FGE BOSTON SCIENTIFIC CORPORATION M0061453530 9378523

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK