BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO TIP NITINOL STONE RETRIEVAL BASKET

    MDR report key: 1081568 · Received July 25, 2008

    Report

    Report Number
    3005099803-2008-01310
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 23, 2008
    Report Date
    June 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND 1 OF THE 4 BASKET WIRES IS BROKEN AT THE KNOT THAT FORMS THE DISTAL TIP OF THE BASKET. THE END OF THE BROKEN WIRE AND THE KNOT WERE INSPECTED UNDER A MICROSCOPE. NO DAMAGE OR DEFECTS WERE FOUND THAT COULD HAVE CAUSED THE BASKET WIRE TO BREAK. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED; NO ANOMALIES WERE NOTED. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND NO OTHER COMPLAINTS HAVE BEEN REPORTED FROM THIS LOT. THE 2008 ZERO TIP BASKET CTW PRODUCT FAMILY TRENDING CHART WAS REVIEWED, NO CURRENT TRENDS IN THE NUMBER OF COMPLAINTS FOR BASKET WIRE BROKE WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT WHILE SETTING UP FOR A STONE RETRIEVAL PROCEDURE IN 2008, ONE OF THE BASKET WIRES ON A ZERO TIP NITINOL STONE RETRIEVAL BASKET BROKE. THE WIRE DID NOT DETACH FROM THE DEVICE. A SECOND BASKET WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED COMPLICATIONS FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZERO TIP NITINOL STONE RETRIEVAL BASKET FFL BOSTON SCIENTIFIC CORPORATION M0063901050 11620646

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK