BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEMINI STONE RETRIEVAL PAIRED WIRE/HELICAL BASKET

    MDR report key: 1243017 · Received November 21, 2008

    Report

    Report Number
    3005099803-2008-06654
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 22, 2008
    Report Date
    October 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE DEVICE HAS NOT BEEN REC'D FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN URETEROSCOPY PROCEDURE THE BASKET BROKE. A GEMINI 4/0/120 HAD BEEN ADVANCED TO RETRIEVE A STONE THAT "WASN'T BIG". THE BASKET CAPTURED THE STONE AND DURING WITHDRAWAL, THE ENTIRE HEAD OF THE BASKET "SNAPPED OFF", LEAVING "SOME WIRE, THE ENTIRE BASKET AND THE STONE INSIDE THE PT". THE PHYSICIAN CUT, STARTING AT THE "UVJ" ORIFICE, 3CM UP THE URETER. THE DEVICE FRAGMENTS WERE REMOVED FROM THE PT WITH AN UNSPECIFIED TYPE OF RESECTOSCOPE. THE TARGET STONE WAS ABLE TO BE REMOVED BY USING ANOTHER GEMINI 4/0/120 BASKET. THERE WERE NO ADD'L PT COMPLICATIONS REPORTED. THE PT HAD A FOLEY CATHETER AT THE END OF THE PROCEDURE BUT IS CURRENTLY "STABLE AND DOING FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMINI STONE RETRIEVAL PAIRED WIRE/HELICAL BASKET FFL BOSTON SCIENTIFIC M0063301100 11859608

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R