BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESCAPE NITINOL STONE RETRIEVAL BASKET

    MDR report key: 1130932 · Received August 21, 2008

    Report

    Report Number
    3005099803-2008-03113
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    July 23, 2008
    Report Date
    July 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FFL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE THE BASKET WAS UNABLE TO BE REMOVED. THE TARGET LESION WAS A LARGE STONE IN AN UNSPECIFIED URETERAL LOCATION. A 120CM ESCAPE STONE RETRIEVAL BASKET HAD BEEN SELECTED AND ADVANCED TO RETRIEVE THE STONE. THE STONE HAD BEEN CAPTURED AND THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE BASKET AND STONE, BUT THE DEVICE COULD NOT BE REMOVED FURTHER THAN THE URETERAL ORIFICE. THE PHYSICIAN ATTEMPTED TO "DE-BASKET" THE STONE BUT WAS UNABLE TO. THE PHYSICIAN CUT THE BASKET NEAR THE HANDLE OUTSIDE OF THE PATIENT, AND LEFT THE WORKING LENGTH OF THE DEVICE AND THE BASKET INSIDE THE PATIENT. THE LOCATION OF THE DEVICE INCLUDES THE LOWER URETER, THE BLADDER AND THE URETHRA. AN UNSPECIFIED STENT WAS DEPLOYED IN THE URETER. THE PATIENT WAS ABLE TO PASS THE BROKEN PIECES OF THE BASKET ON HIS OWN. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESCAPE NITINOL STONE RETRIEVAL BASKET FFL BOSTON SCIENTIFIC M0063902010 11320195

    Patients

    Seq Age Sex Outcome Treatment
    1 Other