This report pertains to a lithovue flexscope and a zero tip baskets used during the same procedure.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, right retrograde pyelogram with fluoroscopic interpretation, right ureteroscopy performed on (b)(6) 2018.During the procedure, the patient experienced right perinephric abscess and urinary tract infection requiring intervention.
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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, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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