Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemorrhage/Bleeding (1888); Renal Failure (2041)
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Event Date 09/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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Date of event: the exact date is unknown; however, it was reported that the event occurred in (b)(6) 2020.The complainant was unable to report the device suspected upn and lot number; therefore, the manufacture date and expiration date are unknown.Imdrf patient codes e130501 and e0506 capture the reportable event of acute kidney injury and hemorrhage.Imdrf impact codes f19 and f23 capture the reportable event of surgical intervention and unexpected medical intervention.
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Event Description
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This report pertains to one of two devices used in the same patient and procedure.It was reported to boston scientific corporation that a nephromax balloon and a percutaneous access needle were used during a left percutaneous nephrolithotomy procedure performed in (b)(6) 2020.The patient experienced hemorrhage and acute kidney injury (aki), requiring transfusion and interventional radiology (ir) embolization.
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Manufacturer Narrative
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Block b3: date of event: the exact date is unknown; however, it was reported that the event occurred in (b)(6) 2020.Block d4, h4: the complainant was unable to report the device suspected upn and lot number; therefore, the manufacture date and expiration date are unknown.Block h6: imdrf patient codes e130501 and e0506 capture the reportable event of acute kidney injury and hemorrhage.Imdrf impact codes f19 and f2302 capture the reportable event of surgical intervention and blood transfusion.Block h11: correction - block h6 (impact code) has been corrected.
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Event Description
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Note: this report pertains to one of two devices used in the same patient and procedure.It was reported to boston scientific corporation that a nephromax balloon and a percutaneous access needle were used during a left percutaneous nephrolithotomy procedure performed in (b)(6) 2020.The patient experienced hemorrhage and acute kidney injury (aki), requiring transfusion and interventional radiology (ir) embolization.
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Search Alerts/Recalls
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