BOSTON SCIENTIFIC CORPORATION INTRODUCER NEEDLES; CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
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Model Number M0067001210 |
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 03/01/2018 |
Event Type
Injury
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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 an imager ii, nephromax balloon, percutaneous access needle and 8/10 dilator sheath set were used during a right percutaneous nephrolithotomy procedure performed in (b)(6) 2018.The patient experienced hemorrhage and acute kidney injury (aki).The patient had to be readmitted and required interventional radiology embolization and transfusion.
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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) 2018.The complainant was unable to report the device suspected 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 f08, f19 and f23 capture the reportable events of readmission, interventional radiology embolization and 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 an imager ii, nephromax balloon, percutaneous access needle and 8/10 dilator sheath set were used during a right percutaneous nephrolithotomy procedure performed in (b)(6) 2018.The patient experienced hemorrhage and acute kidney injury (aki), requiring readmission, interventional radiology (ir) embolization and 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) 2018.Block d4, h4: the complainant was unable to report the device suspected lot number; therefore, the manufacture date and expiration date are unknown.Block h6: imdrf patient codes e130501 and e0506 capture the reportable events of acute kidney injury and hemorrhage.Imdrf impact codes f08, f19 and f2302 capture the reportable events of readmission, interventional radiology embolization and transfusion.
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