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Model Number M0063901050 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Sepsis (2067)
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Event Date 07/19/2019 |
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 report pertains to a lithovue flexscope and a zero tip baskets 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 lithovue flexscope was used during a cystourethroscopy with left ureteral stent placement, left retrograde pyelogram with fluoroscopic interpretation, left ureteroscopy with stone extraction without laser procedure performed on (b)(6) 2019.During procedure, the patient experienced sepsis and a medication was required to treat the complication.
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Search Alerts/Recalls
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