Report source: clinical study: (b)(4) (b)(6) registry.(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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Note: this report is one of two complaints that pertain to the same event (mfr report # 3005099803-2022-00463 and mfr.Report # 3005099803-2022-00462).It was reported to boston scientific corporation that a double-j contour ureteral stents were used during a stent placement procedure in the left and right ureter under flouroscopy and cystoscopy, performed on (b)(6) 2021 as part of the (b)(4) (b)(6)study.The stent placement procedure was indicated for renal papillary necrosis.On (b)(6) 2021, the left and right side stent was successfully implanted to the patient.The patient was prescribed with acetaminophen (tylenol), antibiotic and narcotic analgesics (opioids) at discharge.No issues were noted with the devices.Post procedure, on (b)(6) 2021, moderate flank pain was experienced by the patient.Oxycodone and oxybutynin 5mg were given as medication for pain.The event was considered to be resolved as of (b)(6) 2022.On (b)(6) 2022, the stents were removed successfully in the operating room as per initial plan.Stents were not difficult to remove.Pain control (general anesthesia) was required during stent removal.There were no new stents implanted.In the physician's assessment, the relationship between the procedure and the event is possibly related, there is no relationship between the adverse event and the bsc guidewire, the stent implant procedure, and the stent removal procedure as 'not related' relationship between the adverse event.
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