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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Note: this event pertains to a zero tip basket and lithovue flexscope used in the same procedure.It was reported to boston scientific corporation, through a post market clinical follow up (pmcf) of retrospective data collection, that a zero tip basket and lithovue flexscope was used during cystourethroscopy with left ureteral stent placement, cystourethroscopy with right ureteral stent placement, left retrograde pyelogram with fluoroscopic interpretation, left ureteroscopy with laser lithotripsy, right retrograde pyelogram with fluoroscopic interpretation, right ureteroscopy with laser lithotripsy procedures performed on (b)(6) 2018.During procedure, no visual clearance of stone but residual fragments appeared small enough to pass.The patient experienced urinary tract infection and a medication was required to treat the complication.
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