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Model Number M0063901050 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Renal Failure (2041)
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Event Date 06/08/2021 |
Event Type
Injury
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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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Event Description
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Note: this event pertains to a zero tip basket and lithovue flexscope used in 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 left ureteroscopy, left ureteroscopy with laser lithotripsy; right ureteroscopy, right ureteroscopy with stone extraction without laser procedures performed on (b)(6), 2021.The patient experienced acute kidney injury and required endoscopic intervention not under general anesthesia.
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Search Alerts/Recalls
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