BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO TIP NITINOL STONE RETRIEVAL BASKET

    MDR report key: 1914941 · Received December 6, 2010

    Report

    Report Number
    3005099803-2010-04996
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 11, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY WAS UNABLE TO CONFIRM THE EXACT UPN OF THE PRODUCT. THE LOT NUMBER IS NOT KNOWN PER COMPLAINANT; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE CAN NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE REVEALED THE DEVICE POUCH AND LABEL WERE MISSING. THE ONLY PACKAGING COMPONENTS RETURNED WHERE THE TRAY AND PACKING FOAM. THE BOX, POUCH, LABEL, OR DFU WERE NOT RETURNED. A FUNCTIONAL EVALUATION WAS PERFORMED. WHEN THE HANDLE WAS ACTUATED, THE BASKET WOULD OPEN AND CLOSE WITHOUT ISSUE WHEN HELD STRAIGHT AND IN A LOOP. THE BASKET AND ALL BASKET WIRES WERE PRESENT AND ATTACHED. HOWEVER, BASED ON THE ANALYSIS, THE FAILURE MODE IDENTIFIED IN THE COMPLAINT COULD NOT BE CONFIRMED. IT IS HIGHLY UNLIKELY THAT A DEVICE WAS PACKAGED IN PRODUCTION, SHIPPED THROUGH THE STERILIZATION FACILITY, PROCESSED THROUGH THE DISTRIBUTION CENTER(S), AND ULTIMATELY SHIPPED TO THE CUSTOMER WITHOUT BEING ENCLOSED IN A LABELED POUCH. IT IS POSSIBLE THAT THE POUCH WAS REMOVED AT THE COMPLAINT FACILITY AND ONLY THE TRAY WAS PROVIDED DURING THE PROCEDURE. SINCE THE COMPLAINT FAILURE MODE COULD NOT BE CONFIRMED, AND THERE ARE MULTIPLE POTENTIAL ROOT CAUSES, THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT IS DETERMINED TO BE UNDETERMINABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE ZERO TIP NITINOL RETRIEVAL BASKET WAS RECEIVED WITHOUT OUTER PACKAGING AND IDENTIFYING LABELS. THE EVENT OCCURRED DURING UNPACKING. THEREFORE, NO PATIENT WAS INVOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE ZERO TIP NITINOL RETRIEVAL BASKET WAS RECEIVED WITHOUT OUTER PACKAGING AND IDENTIFYING LABELS. THE EVENT OCCURRED DURING UNPACKING. THEREFORE, NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZERO TIP NITINOL STONE RETRIEVAL BASKET DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC - SPENCER UNK491

    Patients

    Seq Age Sex Outcome Treatment
    1