Clinical study: (b)(6) registry.(b)(4).The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.If any further relevant information is received, a supplemental mdr will be filed.
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It was reported to boston scientific corporation that a tria ureteral stent was used in a stent placement study procedure for stone management for stones in the right ureter performed on (b)(6) 2022 as part of the (b)(6) clinical study.On (b)(6) 2022, the tria ureteral stent was successfully placed for stone management for stones in the right ureter under fluoroscopy.No issues were reported with the device during placement.According to the complainant, following the procedure, the patient had experienced increased urethral pain.The patient was given toradol to treat the pain.On (b)(6) 2022 the event was considered resolved.On (b)(6) 2022, during the planned stent removal procedure, the stent was successfully removed without any difficulty.Local anesthesia was required for pain.There were no new device implanted.No issues were noted with the devices during removal.
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