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 left percutaneous nephrolithotomy procedure performed in (b)(6) 2020.The patient experienced septic shock due to obstruction and required admission to intensive care unit (icu), antibiotics, vasopressor, and a cystoscopy stent.
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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 e2328 and e233605 capture the reportable event of obstruction/occlusion and septic shock.Imdrf impact codes f2303, f0801 and f2301 capture the reportable events of medication required, intensive care and additional device required.
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