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Model Number M0063901050 |
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 12/22/2017 |
Event Type
Injury
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Event Description
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Note: 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 lithovue flexscope and a zero tip basket were used during a cystourethroscopy with left ureteral stent placement, left renal ultrasound with interpretation, left ureteroscopy with laser lithotripsy, right ureteroscopy with stone extraction without laser procedure performed on (b)(6) 2017.It was reported that the patient experienced urinary tract infection and a medication was required for treatment.
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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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