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 infundibulotomy, left retrograde pyelogram with fluoroscopic interpretation procedure performed on (b)(6) 2018.Post procedure, the patient experienced hematuria, dysuria, urinary retention and pain.The patient presented to the emergency room with fever and nausea.It was reported after ureteral stent removal the patient still had left flank pain however less severe.The patient was given medications to treat these complications.
|
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 and if there is any further relevant information from that review, a supplemental medwatch will be filed.
|