Date of event: the exact date is unknown; however, it was reported that the event occurred in (b)(6) 2018.The complainant was unable to report the device suspected lot number; therefore, the manufacture date and expiration date are unknown.Imdrf patient code e1310 capture the reportable event of pyelonephritis.Imdrf impact code f2301 capture the reportable event of placement of percutaneous nephrostomy tube.
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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 right percutaneous nephrolithotomy procedure performed in (b)(6) 2018.The patient experienced pyelonephritis and is required for placement of a percutaneous nephrostomy tube.
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