This report pertains to one of three devices used in the same patient and procedure.It was reported to boston scientific corporation that an imager ii, nephromax balloon and percutaneous access needle were used during a percutaneous nephrolithotomy procedure performed in (b)(6) 2021.The patient experienced pseudoanuerysm and sepsis, requiring readmission, interventional radiology (ir) embolization and iv antibiotics.
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Date of event: the exact date is unknown; however, it was reported that the event occurred in march 2021.The complainant was unable to provide the suspected device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Imdrf patient code e0513 captures the reportable event of pseudoaneurysm.Imdrf patient code e0306 captures the reportable event of sepsis.Imdrf impact code f2303 captures the reportable event of medication required.Imdrf impact code f08 captures the reportable event of hospitalization.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.
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