It was reported to boston scientific corporation, through a post market clinical follow up (pmcf) of retrospective data collection, that a zero tip basket was used during a left antegrade nephrostogram, left nephrostomy tube placement, left percutaneous nephrolithotomy, left renal access and dilation, left renal ultrasound with interpretation, left retrograde pyelogram with fluoroscopic interpretation procedure performed on (b)(6) 2017.During procedure, stone was not cleared and no further procedure was planned.The patient experienced sepsis and urinary tract infection.Medication was required and the patient stayed longer in the hospital than the intended procedure date.
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The complainant was unable to provide the suspect 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 failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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