BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEMINI

    MDR report key: 16246046 · Received January 26, 2023

    Report

    Report Number
    3005099803-2023-00243
    Event Type
    Injury
    Date Received
    January 26, 2023
    Date of Event
    November 4, 2019
    Report Date
    January 26, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK E: THIS EVENT WAS REPORTED BY POST MARKET CLINICAL RESEARCH SPECIALIST II. THE INITIAL REPORTER FACILITY NAME IS: (B)(6). (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION, THROUGH A POST MARKET CLINICAL FOLLOW UP (PMCF) OF RETROSPECTIVE DATA COLLECTION, THAT A GEMINI BASKET WAS USED DURING A CYSTO/URETERO W/LITHOTRIPSY (CYSTOURETHROSCOPY, WITH URETEROSCOPY AND/OR PYELOSCOPY; WITH LITHOTRIPSY INCLUDING INSERTION OF INDWELLING URETERAL STENT [EG, GIBBONS OR DOUBLE-J TYPE]) PROCEDURE PERFORMED ON (B)(6) 2019. DURING PROCEDURE, URETERAL PERFORATION OCCURRED. HC STENT URETERAL POLARIS IS A POSSIBLE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823755 GEMINI DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention