BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEMINI PAIRED WIRE HELICAL BASKET

    MDR report key: 841473 · Received April 24, 2007

    Report

    Report Number
    6000043-2007-00045
    Event Type
    Injury
    Date Received
    April 24, 2007
    Date of Event
    March 23, 2007
    Report Date
    March 26, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FFL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER COMPLAINANT CONFIRMED: THE RETURNED GEMINI PAIRED WIRE HELICAL BASKET DOES NOT FUNCTION DUE TO DAMAGE AND SEPARATION FROM THE SHEATH. THE SHEATH IS KINKED IN SEVERAL PLACES. THE DEFORMATION OF THE PINCH VISE THAT IS CAUSED BY CONTACT WITH THE HANDLE CANNULA WAS INSPECTED AND IT WAS FOUND THE HANDLE CANNULA WAS ONLY BEING HELD BY 3MM OF THE PINCH VISE. THE ROOT CAUSE OF THIS COMPLAINT IS A MANUFACTURING ERROR. THE SHEATH S/A FOR THE DEVICE WAS MANUFACTURED LONG OUT OF SPECIFICATION. OUR ENGINEERING TEAM WILL MONITOR THIS FAILURE MODE FOR ANY INCREASE, NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME DUE TO THE VOLUME OF COMPLAINTS OF THIS NATURE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED ON THE PERTINENT LOT; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE FOR SIMILAR COMPLAINTS RELATED TO THE PRODUCT FAMILY WAS CONDUCTED; NO ADDITIONAL COMPLAINTS HAVE BEEN RECORDED. THE MARCH 2007 15-MONTH GEMINI PAIRED WIRE HELICAL BASKET COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO ADVERSE TREND WAS NOTED AND NO DATA POINT EXCEEDED THE COMPLAINT ALERT LIMIT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT IN 2007, A PATIENT UNDERWENT A THERAPEUTIC STONE RETRIEVAL PROCEDURE. DURING THE PROCEDURE, ONE OF THE WIRES ON OUR GEMINI BASKET STONE RETRIEVAL DEVICE DETACHED FROM THE SHEATH WHILE IN THE PATIENT. THE ENTIRE DEVICE WAS RETRIEVED. ANOTHER BOSTON SCIENTIFIC GEMINI BASKET STONE RETRIEVAL DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMINI PAIRED WIRE HELICAL BASKET FFL FFL BOSTON SCIENTIFIC M0063301140 8971122

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention