Date of event: the exact date is unknown; however, it was reported that the event occurred in (b)(6) 2021.The complainant was unable to report the device suspected upn and lot number; therefore, the manufacture date and expiration date are unknown.Imdrf patient code e0731 captures the reportable event of pleural effusion.Imdrf impact code f2301 capture the reportable event of cystoscopy stent exchange.
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Note: this report pertains to one of four devices used in the same patient and procedure.It was reported to boston scientific corporation that a nephromax balloon, 8/10 dilator, percutaneous access needle and sheath imager ii set were used during a left percutaneous nephrolithotomy procedure performed in (b)(6) 2021.The patient experienced pleural effusion and required cystoscopy stent exchange.
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