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 left ureteral stent placement, left retrograde pyelogram with fluoroscopic interpretation, left ureteroscopy with stone extraction without laser procedure performed on (b)(6) 2017.It was reported that the patient stayed longer than the intended surgery date.
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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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