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
Pleural Effusion (2010)
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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 code e0731 captures the reportable event of pleural effusion.Imdrf impact code f2301 capture the reportable event of cystoscopy stent exchange.
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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 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 pleural effusion and required cystoscopy stent exchange.
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Search Alerts/Recalls
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