BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO TIP RETRIEVAL BASKET

    MDR report key: 1193256 · Received October 7, 2008

    Report

    Report Number
    3005099803-2008-05090
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FFL
    PMA / PMN Number
    K020765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED OF AT THE USER FACILITY, AND WILL NOT BE RETURNED FOR EVALUATION, THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE, A BASKET BREAK OCCURRED. THE STONE WAS LOCATED IN AN UNSPECIFIED URETER. THE 1.9 XERO TIP NITINOL STONE RETRIEVAL BASKET WAS ADVANCED TO THE URETER, HOWEVER, UPON CAPTURING A STONE, THE WIRES ON THE BASKET BROKE. IT WAS NOT KNOWN IF THE WIRE BREAKAGE WAS CAUSED BY THE STONE SIZE OR AMOUNT OF PRESSURE APPLIED TO THE BASKET. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 RETRIEVAL BASKET FFL BOSTON SCIENTIFIC M0063901050 0011876053

    Patients

    Seq Age Sex Outcome Treatment
    1