BEUDAMED
    FDA Adverse Event Summary report: N

    BAGLEY STONE RETRIEVAL HELICAL BASKET

    MDR report key: 1934235 · Received December 21, 2010

    Report

    Report Number
    3005099803-2010-04441
    Date Received
    December 21, 2010
    Report Date
    July 12, 2007
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONDITION OF THE SUBJECT UNIT COULD NOT BE FULLY VERIFIED DUE TO THE DEVICE NOT BEING RETURNED. BASED ON THE REVIEW OF PHOTOGRAPHS (ATTACHED), THE BASKET COULD NOT BE OPENED OR CLOSED. IT APPEARS THAT ALL OF THE BASKET WIRES WERE PRESENT AND ATTACHED, BUT IT CANNOT BE CONFIRMED. MOST LIKELY, ONCE THE STONE WAS IN THE BASKET, A LARGE AMOUNT OF FORCE WAS USED IN AN ATTEMPT TO REMOVE THE STONE. IT IS POSSIBLE THAT THE HANDLE CANNULA SLIPPED OUT OF THE PINCH VISE WHILE THE HANDLE WAS PULLED TO REMOVE THE STONE. WITHOUT HAVING THE COMPLAINT DEVICE AVAILABLE TO EXAMINE, IT IS NOT POSSIBLE TO DETERMINE IF THE HANDLE CANNULA WAS PROPERLY INSTALLED INTO THE HANDLE DURING ASSEMBLY. ADDITIONALLY, IT APPEARS THAT THE WORKING LENGTH WAS GRIPPED IN AN AREA WHERE IT EXITED THE SCOPE; THIS MOST LIKELY CAUSED THE KINKS/BENDS IN THE OUTER SHEATH AND WIRE SUB-ASSEMBLY. ONCE THE KINKS AND BENDS WERE CREATED IN THE WORKING LENGTH, THE HANDLE WOULD NOT ACTUATE. IT WAS NOT POSSIBLE TO DETERMINE FROM THE PHOTOGRAPHS, BUT IT IS LIKELY THAT THE OUTER SHEATH IS BUCKLED AT THE DISTAL END OF THE BLACK HEATH SHRINK. THIS WOULD ALSO HINDER THE FUNCTION OF THE DEVICE. IT IS APPARENT THAT THE DEVICE WAS EXPOSED TO SIGNIFICANT FORCES BASED ON THE DAMAGES PRESENTED IN THE PHOTOGRAPHS. BASED ON THE EVENT DESCRIPTION, EVENT INFORMATION, PHOTOGRAPHS OF THE COMPLAINT DEVICE, AND EVALUATION OF SIMILAR DEVICE INVESTIGATIONS, THE MOST PROBABLE ROOT CAUSE CANNOT BE DETERMINED WITHOUT EVALUATING THE COMPLAINT DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BAGLEY HELICAL STONE RETRIEVAL BASKET WAS USED IN A LASER LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6), 2005. ACCORDING TO THE COMPLAINANT, A LASER FIBER WAS USED TO SUCCESSFULLY FRAGMENT THE URETERAL STONE. THE RETRIEVAL BASKET WAS USED TO CAPTURE ONE OF THE FRAGMENTS, HOWEVER URETERAL EDEMA PRECLUDED THE BASKET FROM NAVIGATING THE URETER BACK INTO THE URETEROSCOPE. THE FRAGMENT WAS ATTEMPTED TO BE RELEASED, HOWEVER THE WIRING TO THE LEVER WHICH OPENS AND CLOSES THE BASKET HAD "SNAPPED OFF" OUTSIDE THE PATIENT'S BODY. THE BASKET WAS UNABLE TO BE OPENED, DESPITE A "SNAP" PLACED AT THE END OF THE BROKEN WIRE. THE URETEROSCOPE WAS UNABLE TO SAFELY NAVIGATE THROUGH THE EDEMA, AND THE WORKING CHANNEL WOULD NOT ACCOMMODATE A WIRE. THE LATERAL URETER WAS INCISED, WHICH ALLOWED THE URETEROSCOPE TO REACH THE BASKET. THE LASER FIBER WAS USED TO FURTHER FRAGMENT THE STONE WITHIN THE BASKET, AND THE FRAGMENTS WERE RELEASED. THE BASKET WAS REMOVED FROM THE PATIENT AND WAS DETERMINED TO BE INTACT. A URETERAL CATHETER AND GUIDE WIRE WERE INSERTED, AND EVENTUALLY REPLACED WITH A DOUBLE J URETERAL STENT WITHOUT DIFFICULTY. THE BLADDER WAS EMPTIED, AND THE PATIENT WAS BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAGLEY STONE RETRIEVAL HELICAL BASKET DISLODGER, STONE, BASKET, URETERAL, METAL FFL M0063401220 6927987

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR