BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLO FLEX HYBRID GUIDEWIRES

    MDR report key: 17583804 · Received August 21, 2023

    Report

    Report Number
    17583804
    Event Type
    Malfunction
    Date Received
    August 21, 2023
    Date of Event
    May 25, 2023
    Report Date
    July 19, 2023
    Manufacturer
    HERAEUS MEDICAL COMPONENTS LLC
    Product Code
    EZB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT WITH BILATERAL KIDNEY STONES UNDERWENT CYSTOURETHROSCOPY, RT RETROGRADE PYELOGRAM, RT PERCUTANEOUS RENAL ACCESS AND DILATATION WITH NEPHROLITHOTOMY, RT RETRO/ANTEGRADE FLEXIBLE URETEROSCOPY, LITHOTRIPSY, FIBER LASER STONE FRAGMENTATION, MULTIPLE STONE EXTRACTIONS, AND RT RETROGRADE JJ URETERIC STENT INSERTION UNDER GENERAL ANESTHESIA. A 0.038" SOLO FLEX HYBRID GUIDEWIRE WAS USED. IT WAS ADVANCED ALONGSIDE A PREEXISTING STENT AT THE RIGHT URETERIC ORIFICE UP TO THE RIGHT RENAL PELVIS UNDER FLUOROSCOPIC GUIDANCE. POST-OP DAY 2 WHILE AT HOME, THE PATIENT REPORTED DURING URINATION A BLACK FLEXIBLE TUBE WAS PASSED. AT A POST-OP OFFICE VISIT WHEN SHOWN A SOLO FLEX GUIDEWIRE TIP BELIEVES THAT IS WHAT WAS PASSED AND PROVIDED A PHOTO. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483430 SOLO FLEX HYBRID GUIDEWIRES STYLET FOR CATHETER, GASTRO-UROLOGY EZB HERAEUS MEDICAL COMPONENTS LLC HW38FS

    Patients

    Seq Age Sex Outcome Treatment
    1 24090 DA Male