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Model Number M0061903220 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Abdominal Pain (1685)
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Event Date 03/13/2020 |
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 is not available for return; 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 report # 3005099803-2020-01695).It was reported to boston scientific corporation that the tria ureteral stents were used in a stent placement procedure for stone management in the right and left ureters performed on (b)(6) 2020 as a part of the (b)(6) clinical study.On (b)(6) 2020, the stents were successfully implanted in the right and left ureters, and the patient was prescribed alpha blocker and nsaids at discharge.No issues were reported with the device during placement.According to the complainant, during the planned stent removal procedure, on (b)(6) 2020, the stent was successfully removed from the patient via retrieval line without any difficulty.Reportedly, the patient experienced abdominal pain and was given morphine, toradol, and hydrocodone.There were no new device implanted.No issues were noted with the devices during removal.On (b)(6) 2020, the event was considered resolved.
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Manufacturer Narrative
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Block g3: clinical study: double-j registry.Block h6: patient code e1002 captures the reportable event of abdominal pain.Block h10: the complainant indicated that the device is not available for return; 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 report #3005099803-2020-01695 mfr.Report #3005099803-2020-01696).It was reported to boston scientific corporation that the tria ureteral stents were used in a stent placement procedure for stone management in the right and left ureters performed on (b)(6) 2020 as a part of the double-j registry clinical study.On (b)(6) 2020, the stents were successfully implanted in the right and left ureters, and the patient was prescribed alpha blocker and nsaids at discharge.No issues were reported with the device during placement.According to the complainant, during the planned stent removal procedure, on (b)(6) 2020, the stent was successfully removed from the patient via retrieval line without any difficulty.Reportedly, the patient experienced abdominal pain and was given morphine, toradol, and hydrocodone.There were no new device implanted.No issues were noted with the devices during removal.On (b)(6) 2020, the event was considered resolved.Additional information received that the relationship to study device is not related.
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Search Alerts/Recalls
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