Model Number M0067001210 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Sepsis (2067); Obstruction/Occlusion (2422)
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Event Date 02/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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Date of event was approximated to (b)(6) 2021, as no exact date was reported.The complainant was unable to report the device suspected lot number; therefore, the manufacture date and expiration date are unknown.Imdrf patient code e0306 captures the reportable event of sepsis.Imdrf patient code e2328 captures the reportable event of obstruction.Imdrf impact code f08 captures the reportable event of hospitalization.Imdrf impact code f19 captures the reportable event of surgical intervention.
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Event Description
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It was reported to boston scientific corporation that a percutaneous access needle was used during a percutaneous nephrolithotomy procedure performed in (b)(6) 2021.The patient experienced sepsis /obstruction and required readmission/ir perc tube placement.
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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 february 2021.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 e0306 and e2328 capture the reportable event of sepsis and obstruction.Imdrf impact codes f08 and f19 capture the reportable event of hospitalization and surgical intervention.Block h11: correction: block b5 (describe event or problem) and h10 (additional mfr narrative).
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Event Description
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It was reported to boston scientific corporation that a percutaneous access needle was used during a percutaneous nephrolithotomy procedure performed in (b)(6) 2021.The patient experienced sepsis /obstruction and required readmission/ir perc tube placement.Additional information was received on march 20, 2023: it was clarified that the patient experienced sepsis due to obstruction.The patient undergone interventional radiology percutaneous tube placement and was readmitted.
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Manufacturer Narrative
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Block b3: date of event was approximated to february 1, 2021, as no exact date was reported.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 code e0306 captures the reportable event of sepsis.Imdrf patient code e2328 captures the reportable event of obstruction.Imdrf impact code f08 captures the reportable event of hospitalization.Imdrf impact code f19 captures the reportable event of surgical intervention.
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Event Description
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It was reported that a percutaneous access needle was used during a percutaneous nephrolithotomy procedure performed in (b)(6) 2021.The patient experienced sepsis /obstruction and required readmission/ir perc tube placement.
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Event Description
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It was reported to boston scientific corporation that a percutaneous access needle was used during a percutaneous nephrolithotomy procedure performed in (b)(6) 2021.The patient experienced sepsis /obstruction and required readmission/ir perc tube placement.Additional information was received on march 20, 2023: it was clarified that the patient experienced sepsis due to obstruction.The patient undergone interventional radiology percutaneous tube placement and was readmitted.
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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 february 2021.Block d4, h4: the complainant was unable to report the device suspected lot number; therefore, the manufacture date and expiration date are unknown.Block h2: additional information: block a6 (race) has been updated based on the additional information received on april 25, 2023.Block h6: imdrf patient codes e0306 and e2328 capture the reportable event of sepsis and obstruction.Imdrf impact codes f08 and f19 capture the reportable event of hospitalization and surgical intervention.
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Search Alerts/Recalls
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