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Model Number M0061903230 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Incontinence (1928); Pain (1994); Urinary Incontinence (4572)
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Event Date 02/26/2020 |
Event Type
Injury
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Manufacturer Narrative
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Report source: clinical study: (b)(6).(b)(4): the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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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# 3005099803-2020-01712).It was reported to boston scientific corporation that a tria ureteral stent was used in a stent placement procedure for stone management for stones in the right and left kidneys performed on (b)(6) 2020 as part of the (b)(6) clinical study.On (b)(6) 2020, the tria ureteral stents were successfully implanted in the right and left ureters, and the patient was prescribed alpha blocker, anticholinergic, nsaids, and phenazopyridine at discharged.No issues were noted with the devices.According to the complainant, after the procedure on (b)(6) 2020, the patient had experienced urge incontinence and pain.On (b)(6) the stents were removed at home, due to urge incontinence and pain, without difficulty utilizing the stent retrieval line.The stents were removed, not per the initial plan, 3 days earlier than the intended plan.The patient was given an oral pain control.On (b)(6) 2020 the urge incontinence was considered resolved.On (b)(6) 2020 the pain was considered resolved.
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Manufacturer Narrative
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Block g3: clinical study: u0652 double-j registry.Block h6: patient code e232402 captures the reportable event of urinary incontinence.Patient code e2330 captures the reportable event of pain.Block h10: the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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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# 3005099803-2020-01713 and mfr# 3005099803-2020-01712).It was reported to boston scientific corporation that a tria ureteral stent was used in a stent placement procedure for stone management for stones in the right and left kidneys performed on (b)(6) 2020 as part of the u0652 double-j registry clinical study.On (b)(6) 2020, the tria ureteral stents were successfully implanted in the right and left ureters, and the patient was prescribed alpha blocker, anticholinergic, nsaids, and phenazopyridine at discharged.No issues were noted with the devices.According to the complainant, after the procedure on (b)(6) 2020, the patient had experienced urge incontinence and pain.On (b)(6) 2020, the stents were removed at home, due to urge incontinence and pain, without difficulty utilizing the stent retrieval line.The stents were removed, not per the initial plan, 3 days earlier than the intended plan.The patient was given an oral pain control.On (b)(6) 2020 the urge incontinence was considered resolved.On (b)(6) 2020 the pain was considered resolved.Additional information received that the site updated the relationship to device from causal to not related.
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Manufacturer Narrative
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Block g3: clinical study: u0652 double-j registry.Block h6: imdrf patient code e232402 captures the reportable event of urinary incontinence.Imdrf patient code e2330 captures the reportable event of pain.Block h11: block b5 has been updated based on additional information received on march 16, 2023.
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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# 3005099803-2020-01713 and mfr# 3005099803-2020-01712).It was reported to boston scientific corporation that a tria ureteral stent was used in a stent placement procedure for stone management for stones in the right and left kidneys performed on (b)(6), 2020 as part of the u0652 double-j registry clinical study.On (b)(6), 2020, the tria ureteral stents were successfully implanted in the right and left ureters, and the patient was prescribed alpha blocker, anticholinergic, nsaids, and phenazopyridine at discharged.No issues were noted with the devices.According to the complainant, after the procedure on (b)(6), 2020, the patient had experienced urge incontinence and pain.On (b)(6), 2020, the stents were removed at home, due to urge incontinence and pain, without difficulty utilizing the stent retrieval line.The stents were removed, not per the initial plan, 3 days earlier than the intended plan.The patient was given an oral pain control.On (b)(6), 2020, the urge incontinence was considered resolved.On (b)(6), 2020, the pain was considered resolved.Additional information received on march 02, 2022, that the site updated the relationship to device from causal to not related.Additional information received on march 16, 2023, that the site updated the relationship to device to casual.
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Search Alerts/Recalls
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