BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3005099803-2008-06604

    MDR report key: 1241055 · Received November 20, 2008

    Report

    Report Number
    3005099803-2008-06604
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. 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 FOLLOWING AN URETEROSCOPY WITH STONE EXTRACTION PROCEDURE DEVICE FRAGMENT PASSAGE WITH BURNING URINATION OCCURRED. A GEMINI 4/0/90/14MM BASKET HAD BEEN ADVANCED TO RETRIEVE AN UNSPECIFIED STONE. DURING THE PROCEDURE, A 3CM PORTION OF THE PLASTIC SHEATH DISLODGED INSIDE THE PT. FOLLOWING THE PROCEDURE, THE PT ELIMINATED THE DEVICE FRAGMENT WITH URINATION AND NOTED A BURNING SENSATION DURING URINATION. THE PT'S CURRENT CONDITION IS UNK. DESPITE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFO, NO INFO HAS BEEN REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FFL BOSTON SCIENTIFIC M0063302080 11789819

    Patients

    Seq Age Sex Outcome Treatment
    1 Other