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 right nephrostomy tube placement, right percutaneous nephrolithotomy, right renal access and dilation, right renal ultrasound with interpretation and right ureteroscopy procedure performed on (b)(6) 2018.During the procedure, the patient experienced bleeding requiring transfusion and intervention under general anesthesia.
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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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