BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO TIP RETRIEVAL BASKET

    MDR report key: 1325848 · Received February 26, 2009

    Report

    Report Number
    3005099803-2008-03539
    Event Type
    Malfunction
    Date Received
    February 26, 2009
    Date of Event
    March 19, 2008
    Report Date
    March 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION-SPENCER
    Product Code
    FFL
    PMA / PMN Number
    K020765
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PACKAGING WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE EVENT COULD NOT BE CONFIRMED. HOWEVER, THE ACTUAL DEVICE WAS RETURNED AND EVALUATED. A VISUAL ANALYSIS OF THE RETURNED DEVICE FOUND 1 OF THE 4 BASKET WIRES WAS BROKEN AT THE KNOT THAT FORMS THE TIP OF THE BASKET. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ISSUES THAT COULD BE ASSOCIATED WITH THIS INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION, THAT A ZEROTIP STONE RETRIEVAL DEVICE WAS OPENED FOR USE IN A PROCEDURE. DURING UNPACKING THE DEVICE, THEY NOTICED THAT THE PACKAGING HAD BEEN OPENED AND WAS NO LONGER STERILE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ZEROTIP STONE RETRIEVAL DEVICE WITH NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZERO TIP RETRIEVAL BASKET URETERAL STONE BASKET FFL BOSTON SCIENTIFIC CORPORATION-SPENCER M0063901050 0011051306

    Patients

    Seq Age Sex Outcome Treatment
    1