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 Problem
Transient Ischemic Attack (2109)
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Event Date 10/01/2017 |
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) 2017.The complainant was unable to report the device suspected lot number; therefore, the manufacture date and expiration date are unknown.Imdrf patient codes (b)(6) capture the reportable event of transient ischemic attack.Imdrf impact codes (b)(4) capture the reportable event of unexpected medical intervention.
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Event Description
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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 left percutaneous nephrolithotomy procedure performed in (b)(6) 2017.The patient experienced transient ischemic attack and required neurology evaluation.
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Search Alerts/Recalls
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