BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEMINI 11MM BASKET

    MDR report key: 1003026 · Received February 21, 2008

    Report

    Report Number
    3005099803-2008-00189
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 29, 2008
    Report Date
    January 30, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. A REVIEW OF THE DEVICE HISTORY (DHR) WAS PERFORMED ON THE PERTINENT LOT; NO ANOMALIES WERE NOTED. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND NO OTHER COMPLAINTS HAVE BEEN REPORTED FROM THIS LOT. THE DECEMBER 2007 15-MONTH 11MM GEMINI COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED, NO ADVERSE TREND WAS NOTED. ATTEMPTING TO REMOVE A STONE THAT IS TOO LARGE IS CONTRAINDICATED IN THE DFU (DIRECTIONS FOR USE).

    Description of Event or Problem · 1

    IN 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT A GEMINI RETRIEVAL BASKET WAS USED IN A STONE REMOVAL PROCEDURE ON A MALE PT (WEIGHT UNK) THAT OCCURRED ON THE DAY BEFORE. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO EXTRACT A LARGE STONE FROM THE PT BUT THE BASKET BECAME STUCK. CONSEQUENTLY, THE PHYSICIAN OPTED TO CUT THE HANDLE AND LEFT THE BASKET INSIDE THE PT. THE PT WAS ADMITTED TO ANOTHER HOSP FOR FURTHER TREATMENT. A STENT WAS PLACED AND THE PT WAS KEPT OVERNIGHT FOR OBSERVATION. ACCORDING TO THE COMPLAINANT, THE BASKET OF THE GEMINI RETRIEVAL BASKET DEVICE WAS RETRIEVED (UNK METHOD) AND THE LARGE STONE WAS REMOVED BY A LASER PROCEDURE. A USER FACILITY MEDWATCH WAS RECEIVED ON 02/15/2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMINI 11MM BASKET FFL FFL BOSTON SCIENTIFIC CORPORATION M0063301040 11327380

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R