BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLO FLEX HYBRID GUIDEWIRES

    MDR report key: 17715686 · Received September 8, 2023

    Report

    Report Number
    3008988055-2023-00009
    Event Type
    Malfunction
    Date Received
    September 8, 2023
    Date of Event
    May 25, 2023
    Report Date
    September 8, 2023
    Manufacturer
    HERAEUS MEDICAL COMPONENTS LLC
    Product Code
    EZB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUBMISSION DOES NOT CONSTITUTE A DETERMINATION OR ADMISSION THAT THE DEVICE HAS MALFUNCTIONED OR THAT THE DEVICE WAS RELATED TO A DEATH OR INJURY.

    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
    712918 SOLO FLEX HYBRID GUIDEWIRES STYLET FOR CATHETER, GASTRO-UROLOGY EZB HERAEUS MEDICAL COMPONENTS LLC HW38FS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Other