BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR¿

    MDR report key: 2130948 · Received June 16, 2011

    Report

    Report Number
    3005099803-2011-02044
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FAD
    PMA / PMN Number
    K974541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR URETERAL STENT WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE. ACCORDING TO THE COMPLAINANT, WHEN THE PHYSICIAN WAS PLACING THE STENT, USING A BENTSON-TYPE GUIDEWIRE, THE STENT POSITIONER BECAME DIFFICULT TO PULL AND THE STENT BROKE IN HALF. THE PATIENT WAS SENT TO THE OPERATING ROOM AT THE SAME HOSPITAL ON THE SAME DAY FOR REMOVAL OF THE STENT HALF. THE SURGEON IN THE OPERATING ROOM WAS ABLE TO REMOVE THE PROXIMAL STENT HALF BY USE OF FORCEPS. DURING THIS PROCEDURE, ANOTHER CONTOUR URETERAL STENT WAS PLACED WITHOUT COMPLICATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE."

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR URETERAL STENT WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE. ACCORDING TO THE COMPLAINANT, WHEN THE PHYSICIAN WAS PLACING THE STENT, USING A BENTSON-TYPE GUIDEWIRE, THE STENT POSITIONER BECAME DIFFICULT TO PULL AND THE STENT BROKE IN HALF. THE PATIENT WAS SENT TO THE OPERATING ROOM AT THE SAME HOSPITAL ON THE SAME DAY FOR REMOVAL OF THE STENT HALF. THE SURGEON IN THE OPERATING ROOM WAS ABLE TO REMOVE THE PROXIMAL STENT HALF BY USE OF FORCEPS. DURING THIS PROCEDURE, ANOTHER CONTOUR URETERAL STENT WAS PLACED WITHOUT COMPLICATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR¿ STENT, URETERAL FAD BOSTON SCIENTIFIC - MARLBOROUGH M0061802420 13346375

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR