BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL

    MDR report key: 1133733 · Received August 20, 2008

    Report

    Report Number
    3005099803-2008-03094
    Event Type
    Malfunction
    Date Received
    August 20, 2008
    Report Date
    July 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRANSURETHRO-URETERAL LITHOTRIPSY (TUL) PROCEDURE, THE BASKET WAS UNABLE TO BE CLOSED. THE BASKET WAS OPENED IN THE PT'S URETER. UPON ATTEMPTING TO CLOSE THE BASKET, IT WAS NOT POSSIBLE TO DO SO. THE BASKET WAS REMOVED IN AN INCOMPLETELY CLOSE STATE WITHOUT INJURY TO THE PT AND THE PROCEDURE WAS COMPLETED. THE PT WAS REPORTED TO BE GOOD POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL FGO - DISLODGER, STONE FLEXIBLE FGO BOSTON SCIENTIFIC CORPORATION M0063903100 0000604259

    Patients

    Seq Age Sex Outcome Treatment
    1