The complainant was unable to provide the device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The device has not been received for analysis.Upon receipt and completion of the device analysis and if there is any further relevant information from that review, a supplemental medwatch will be filed.
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It was reported to boston scientific corporation, through a post market clinical follow up (pmcf) of retrospective data collection, that a lithovue flexscope was used during a cystourethroscopy with right ureteral stent placement, cystourethroscopy with right ureteral stent removal, right retrograde pyelogram with fluoroscopic interpretation, right ureteroscopy procedure performed on (b)(6) 2017.During procedure, it was reported there was significant inflammation of ureter and kidney collecting system.No stone seen, but multiple clots and blood urine in kidney.Suboptimal visualization during diagnostic ureteroscopy.The patient experienced inflammation and a urinary tract infection.The patient was given medication.
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