BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO TIP NITINOL STONE RETRIEVAL BASKET

    MDR report key: 1171327 · Received September 17, 2008

    Report

    Report Number
    3005099803-2008-04640
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    July 23, 2008
    Report Date
    August 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARING FOR A CYSTO PROCEDURE THE RETRIEVAL BASKET FAILED TO OPERATE. A BASKET ZERO TIP KNOT 2.4X4X120 BASKET WAS BEING PREPARED FOR USE WHEN IT WAS NOTED THAT THE DEVICE "DID NOT WORK". THE DEVICE WOULD NOT OPEN OR CLOSE, THE DEVICE WAS NOT USED IN THE PROCEDURE AND DID NOT CONTACT THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZERO TIP NITINOL STONE RETRIEVAL BASKET NONE FFL BOSTON SCIENTIFIC M0063901010 11441429

    Patients

    Seq Age Sex Outcome Treatment
    1