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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 11/07/2017 |
Event Type
Injury
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Manufacturer Narrative
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The complainant was unable to provide the 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 device analysis, 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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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 zero tip basket were used during a cystourethroscopy with left ureteral stent placement, cystourethroscopy with right ureteral stent placement, left retrograde pyelogram with fluoroscopic interpretation, left ureteroscopy with laser lithotripsy, right retrograde pyelogram with fluoroscopic interpretation, right ureteroscopy with laser lithotripsy procedure performed on (b)(6) 2017.It was reported that the patient experienced urinary tract infection and a medication was required.
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Search Alerts/Recalls
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