BOSTON SCIENTIFIC CORPORATION INTRODUCER NEEDLES; CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
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Model Number M0067001210 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Sepsis (2067); Pseudoaneurysm (2605)
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Event Date 03/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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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 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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Event Description
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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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Search Alerts/Recalls
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