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 (pcnl) procedure performed in (b)(6) 2016.The patient experienced gross hematuria and was admitted for observation.In the physician's assessment the event was not related to the imager ii and 8/10 dilator sheath set but was causally related to the procedure.In the physician's assessment the event was probably related to the nephromax balloon and percutaneous access needle but was causally related to the procedure.
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Patient's race: asian american 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 upn and lot number; therefore, the manufacture date and expiration date are unknown.Imdrf patient code e1302 captures the reportable event of hematuria.Imdrf impact code f08 captures the reportable event of hospitalization.
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