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Model Number M0061752630 |
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 03/22/2022 |
Event Type
Injury
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Manufacturer Narrative
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Study: (b)(6).(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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Event Description
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It was to 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 acetaminophen (tylenol).No issues were noted with the device.On (b)(6) 2022, the patient had experienced a right flank pain.The patient was given ketolac 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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Event Description
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It was to 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 acetaminophen (tylenol).No issues were noted with the device.On (b)(6) 2022, the patient had experienced a right flank pain.The patient was given ketolac to treat the pain.During the planned stent removal performed on march 22, 2022, the percuflex plus ureteral stent was successfully removed from the patient without any difficulty.There were no new devices implanted.On (b)(6)2022, the event was considered resolved.Additional information received on october 28, 2022, stated that the onset date was on (b)(6) 2022, and the stop date was on (b)(6) 2022.The event of moderate right-sided flank pain, and requiring ketorolac, was reported to be probably related to the procedure and device, and not related to stent removal.
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Manufacturer Narrative
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Additional information received on october 28, 2022: block b5: event description.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.
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Search Alerts/Recalls
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