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Model Number M0061752620 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pain (1994)
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Event Date 02/18/2022 |
Event Type
Injury
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Event Description
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It was reported to boston scientific corporation that a previously implanted percuflex plus ureteral stent was removed from the right ureter, performed on (b)(6) 2022 as part of the (b)(6) clinical study.On (b)(6) 2022, the percuflex plus ureteral stent was successfully placed for stone management in the right ureter, and the patient was prescribed the discharge medications, acetaminophen (tylenol) and non steroidal anti inflammatory drugs (nsaid)s.No issues were noted with the device.On (b)(6) 2022, the patient had experienced a right flank pain.The patient was given ibuprofen, and flomax to treat the pain.During the planned stent removal performed on (b)(6) 2022, the percuflex plus ureteral stent was successfully removed from the patient without any difficulty.There were no new device implanted.On (b)(6) 2022 the event was considered resolved.
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Manufacturer Narrative
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Study: (b)(6) clinical study.(b)(4).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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Manufacturer Narrative
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Block g3: study: u0652 double-j registry clinical study.Block h6: medical problem code e2330 is being used to capture the reportable issue of pain.Patient impact code f2303 captures the reportable event of medication required.Block h10: block b5 have been updated based on additional information received october 30, 2022, november 1, 2022, and november 3, 2022.
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Event Description
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It was reported to boston scientific corporation that a previously implanted percuflex plus ureteral stent was removed from the right ureter, performed on (b)(6) 2022 as part of the u0652 double-j registry clinical study.On (b)(6) 2022, the percuflex plus ureteral stent was successfully placed for stone management in the right ureter, and the patient was prescribed the discharge medications, acetaminophen (tylenol) and non steroidal anti inflammatory drugs (nsaid)s.No issues were noted with the device.On (b)(6) 2022, the patient had experienced a right flank pain.The patient was given ibuprofen, and flomax to treat the pain.During the planned stent removal performed on (b)(6) 2022, the percuflex plus ureteral stent was successfully removed from the patient without any difficulty.There were no new device implanted.On (b)(6) 2022 the event was considered resolved.Additional information that the onset date was on february 18, 2022, and the stop date was on (b)(6) 2022.The event of moderate right flank pain, treated with ibuprofen and flomax, and reported by the site to be probably related to the procedure and device, and not related to stent removal.
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Search Alerts/Recalls
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