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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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 retrograde pyelogram with fluoroscopic interpretation, left ureteroscopy with laser lithotripsy procedure performed on (b)(6) 2019.During procedure, the patient experienced urinary tract infection, nausea, vomiting and acute kidney injury (aki).The patient stayed longer in the hospital than the intended procedure date and was required a medication to treat the complication.
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