Note: 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 left ureteral stent placement, left nephrostomy tube placement, left percutaneous nephrolithotomy, left renal access and dilation, left renal ultrasound with interpretation, left ureteroscopy with laser lithotripsy procedure performed on (b)(6) 2017.During the procedure, the patient experienced a systemic inflammatory response syndrome and a medication was required.The patient was hospitalized and discharge more than a week after the surgery.
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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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