BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMINI PAIRED WIRE HELICAL BASKET

    MDR report key: 1193357 · Received October 7, 2008

    Report

    Report Number
    3005099803-2008-05122
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    April 25, 2008
    Report Date
    September 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER PRODUCT EVAL IS IN PROGRESS; RESULTS WILL BE PROVIDED IN A FOLLOW-UP MEDWATCH REPORT.

    Description of Event or Problem · 1

    NOTE: REFER TO MFR REPORT #3005099803-2008-00530. SINCE THE ACCOUNT SITE INADVERTENTLY SENT BACK THE WRONG DEVICE; A NEW COMPLAINT FILE WAS GENERATED IN ORDER TO ADDRESS THE INCORRECT DEVICE. OUR FINDINGS REVEALED THAT THE RETURNED DEVICE WAS FOUND TO BE INTACT, WITH NO SEPARATED COMPONENTS AS STATED IN THE EVENT INFO, AS RECEIVED, IT WAS FOUND THE RETURNED DEVICE WAS DIFFICULT TO FUNCTION WHEN OPENING AND CLOSING THE BASKET. IN ADDITION, THERE IS A LARGE AMOUNT OF FRICTION BETWEEN THE DRIVE WIRE AND SHEATH THAT CAN BE FELT WHEN THE BASKET IS FUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMINI PAIRED WIRE HELICAL BASKET FFL BOSTON SCIENTIFIC M0063301100 11356998

    Patients

    Seq Age Sex Outcome Treatment
    1