BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEGURA BASKET

    MDR report key: 1894151 · Received November 4, 2010

    Report

    Report Number
    1894151
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    September 10, 2010
    Report Date
    November 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FFL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    URETERAL INJURY INTRAOPERATIVELY. IT WAS FELT THAT THERE WAS URETERAL INJURY THAT COULD NOT BE MANAGED BY ENDOSCOPIC MEANS, AND OPEN CONVERSION HAD TO BE PERFORMED. DURING SURGERY IT WAS IDENTIFIED THAT THERE WAS AN AVULSION INJURY AND THE URETER HAD RETRACTED INTO SEVERAL MORE CENTIMETERS ABOVE WITHIN THE ADVENTITIA EVEN THOUGH THE ADVENTITIA REMAINED INTACT. IT WAS FELT THAT PRIMARY URETERAL REPAIR WOULD NOT BE POSSIBLE FOR REIMPLANTATION IN THE BLADDER AND THAT THE BLADDER SHOULD BE MOBILIZED. A BOARI FLAP WAS THEN CREATED BY CREATING A FLAP ON THE LEFT SIDE OF THE BLADDER. PATIENT WAS DISCHARGED WITH NO LASTING INJURY SO DID NOT MEET THE CRITERIA. AFTER INTERNAL QUALITY REVIEW, MD FELT THE BASKET BECAME DISENGAGED, HE FELT RESISTANCE, THE INTERPRETATION FROM THE CHARGE RN WAS THAT IT WAS NOT DUE TO THE BASKET, BUT DUE TO THE STONE/RENAL CALCULI. MD (UROLOGIST) REVIEW FELT IT WAS A KNOWN COMPLICATION OF THIS PROCEDURE. THE DEVICE WAS NOT RETAINED AND WAS DISPOSED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEGURA BASKET STONE RETRIEVAL BASKET FFL BOSTON SCIENTIFIC

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention