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Model Number M0063901050 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemorrhage/Bleeding (1888); Perforation (2001)
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Event Date 05/26/2020 |
Event Type
Injury
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Event Description
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It was reported to boston scientific corporation, through a post market clinical follow up (pmcf) of retrospective data collection, that a zero tip basket was used during a right nephrostomy tube placement, right nephrostomy tube removal, right percutaneous nephrolithotomy, right renal access and dilation, right ureteroscopy with stone extraction without laser procedure performed on (b)(6) 2022.During procedure, patient experienced moderate bleeding due to a small perforation on the back wall of the collection system during placement of an access sheath.Treated with hemostatics at completion.
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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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