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, 8/10 dilator sheath set and percutaneous access needle were used during a percutaneous nephrolithotomy (pcnl) procedure performed in (b)(6) 2016.The patient experienced urinoma and had a cysto stent placed to help drain the urinoma.In the physician's assessment the event was not related to the imager ii, 8/10 dilator sheath set and percutaneous access needle but was causally related to the procedure.In the physician's assessment the event was probably related to the nephromax balloon but was causally related to the procedure.
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Date of event: the exact date is unknown; however, it was reported that the event occurred in (b)(6) 2016.The complainant was unable to report the device suspected lot number; therefore, the manufacture date and expiration date are unknown.Adverse event problem: imdrf patient code e2114 captures the reportable event of urinoma.Imdrf impact codes f2202 and f2301 capture the reportable event of endoscopic procedure and additional device required.
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