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 10/01/2017 |
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) 2017.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 renal failure and hemorrhage.Imdrf impact codes f23 capture the reportable event of transfusion.
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Event Description
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Note: this report pertains to one of four devices used in the same patient and procedure.It was reported to boston scientific corporation that a nephromax balloon, 8/10 dilator, percutaneous access needle and sheath imager ii set were used during a left percutaneous nephrolithotomy procedure performed in (b)(6) 2017.During the procedure, the patient experienced hemorrhage, acute kidney injury (aki) and required transfusion.
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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) 2017.Block d4, h4: the complainant was unable to report the suspected device 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 renal problem and hemorrhage.Imdrf impact code f2302 captures the reportable event of transfusion.
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Event Description
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Note: this report pertains to one of four devices used in the same patient and procedure.It was reported to boston scientific corporation that a nephromax balloon, 8/10 dilator sheath set, percutaneous access needle and imager ii were used during a left percutaneous nephrolithotomy procedure performed in (b)(6) 2017.The patient experienced hemorrhage, acute kidney injury (aki) and required transfusion.
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Search Alerts/Recalls
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