Date of event: the exact date is unknown; however, it was reported that the event occurred in (b)(6) 2020.The complainant was unable to report the device suspected upn and lot number; therefore, the manufacture date and expiration date are unknown.Imdrf patient codes e233603, e0306 and e0506 capture the reportable event of blood loss, hemorrhagic shock and sepsis.Imdrf impact codes f02 and f19 capture the reportable event of surgical intervention and death.
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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 an imager ii, nephromax balloon, percutaneous access needle and 8/10 dilator sheath set were used during a percutaneous nephrolithotomy procedure performed in (b)(6) 2020.The patient had exploratory laparoscopic nephrectomy, and experienced hemorrhagic shock, sepsis and died.It was reported that the cause of death was due to sepsis and not related to the devices used.In the physician's assessment, the devices were related to the procedure.
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