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Model Number M0063901050 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Urinary Tract Infection (2120)
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Event Date 02/23/2018 |
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 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 and zero tip basket was used during a cystourethroscopy with right ureteral stent placement, right retrograde pyelogram with fluoroscopic interpretation, right ureteroscopy procedure performed on (b)(6) 2018.It was reported that the patient experienced right perinephric abscess and urinary tract infection requiring an intervention not under general anesthesia.
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Search Alerts/Recalls
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