Model Number M0061921320 |
Device Problems
Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
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Patient Problems
Hemorrhage/Bleeding (1888); Discomfort (2330)
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Event Date 03/09/2024 |
Event Type
Injury
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Event Description
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Note: this report is one of two complaints that pertain to the same event (mfr report # mfr.Report # 2124215-2024-19164).It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a flexible ureterolithomy plus catheter placement procedure performed on (b)(6) 2024.During the procedure, the stent did not pass through the guidewire.It was noted that the stent was buckled.The stent was soaked in water for approximately 5 to 10 minutes, however, due to the failure to pass, it had to be removed.The procedure had to be canceled because the patient was bleeding, and discomfort was experienced.It was noted that the discomfort experienced was from the specialists with the product problem.There were no additional patient complications reported.
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Manufacturer Narrative
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Imdrf device code a0401 captures the reportable event of stent buckled material, inside the patient.Imdrf patient code e0506 captures the reportable event of bleeding.Imdrf impact code f05 captures the reportable event of delay to treatment.
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Manufacturer Narrative
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Block h6: imdrf device code a0401 captures the reportable event of stent buckled material, inside the patient.Imdrf patient code e0506 captures the reportable event of bleeding.Imdrf impact code f05 captures the reportable event of delay to treatment.Update to block f10, block h6: discomfort.
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Event Description
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It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a flexible ureterolithotomy plus catheter placement procedure performed on (b)(6) 2024.During the procedure, the stent did not pass through the guidewire.It was noted that the stent was buckled.The stent was soaked in water for approximately 5 to 10 minutes, however, due to the failure to pass, it had to be removed.The procedure had to be canceled because the patient was bleeding, and discomfort was experienced.A nephrostomy had to be performed for the patient's bleeding.It was noted that the discomfort experienced was from the specialists with the product problem.There were no additional patient complications reported.
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Search Alerts/Recalls
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