Date of event: the exact date is unknown; however, it was reported that the event occurred in (b)(6) 2021.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 e0513 and e0306 capture the reportable events of pseudoaneurysm and sepsis.Imdrf impact codes f08 and f23 capture the reportable event of required interventional radiology embolization and readmission.
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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 a nephromax balloon, 8/10 dilator, percutaneous access needle and sheath imager ii set were used during a left percutaneous nephrolithotomy procedure performed in (b)(6) 2021.The patient experienced pseudoaneurysm and sepsis and required interventional radiology embolization and readmission.
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