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
Urinary Tract Infection (2120)
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Event Date 07/01/2018 |
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) 2018.The complainant was unable to report the device suspected lot number; therefore, the manufacture date and expiration date are unknown.Imdrf patient code e1310 capture the reportable event of pyelonephritis.Imdrf impact code f2301 capture the reportable event of placement of percutaneous nephrostomy tube.
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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 an imager ii, nephromax balloon, percutaneous access needle and 8/10 dilator sheath set were used during a right percutaneous nephrolithotomy procedure performed in (b)(6) 2018.The patient experienced pyelonephritis and is required for placement of a percutaneous nephrostomy tube.
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Search Alerts/Recalls
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