BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO TIP NITINOL STONE RETRIEVAL BASKET

    MDR report key: 1132759 · Received August 22, 2008

    Report

    Report Number
    3005099803-2008-03631
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 23, 2008
    Report Date
    July 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SAME CASE AS MFR# 3005099803-2008-03581. IT WAS REPORTED THAT DURING A URETEROSCOPY LASER LITHOTRIPSY PROCEDURE, THE BASKET WOULD NOT RE-OPEN. THE STONE WAS LOCATED IN AN UNSPECIFIED URETER. THE BASKET ZERO TIP KNOT 2.4MMX 4MM STONE RETRIEVAL BASKET WAS ADVANCED TO THE URETER AND WAS ABLE TO CAPTURE THE STONE, HOWEVER, PRIOR TO RE-INSERTING THE DEVICE, THE "WIRE ON THE BASKET LOOKED CRIMPED OR BENT". ANOTHER OF THE SAME DEVICE WAS ADVANCED AND SUCCESSFULLY REMOVED A STONE, HOWEVER, PRIOR TO RE-INSERTION, IT WAS NOTED THAT THE HANDLE "WAS NOT WORKING" AND THE PHYSICIAN COULD NOT RE-OPEN THE BASKET. A THIRD OF THE SAME BASKET WAS OBTAINED, HOWEVER, THE DEVICE BECAME STUCK IN THE ENDOSCOPE UPON ADVANCEMENT AND "THE PHYSICIAN CUT THE WIRE NEAR THE HANDLE TO REMOVE IT FROM THE SCOPE". THE PROCEDURE WAS COMPLETED USING AN UNSPECIFIED DEVICE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZERO TIP NITINOL STONE RETRIEVAL BASKET FFL BOSTON SCIENTIFIC M0063901050 0009523806

    Patients

    Seq Age Sex Outcome Treatment
    1