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Model Number M0063901050 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Nausea (1970); Renal Failure (2041); Urinary Tract Infection (2120); Vomiting (2144)
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Event Date 09/23/2019 |
Event Type
Injury
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Event Description
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This report pertains to a lithovue flexscope and a zero tip basket used during the same procedure.It was reported to boston scientific corporation, through a post market clinical follow up (pmcf) of retrospective data collection, that a zero tip basket and lithovue flexscope was used during cystourethroscopy with left ureteral stent placement, left retrograde pyelogram with fluoroscopic interpretation, left ureteroscopy with laser lithotripsy procedure performed on (b)(6) 2019.During procedure, the patient experienced urinary tract infection, nausea, vomiting and acute kidney injury (aki).The patient stayed longer in the hospital than the intended procedure date and was required a medication to treat the complication.
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Manufacturer Narrative
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The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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Search Alerts/Recalls
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