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Model Number M0061752650 |
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 04/15/2022 |
Event Type
Injury
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Manufacturer Narrative
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Study: u0652 double-j registry 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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Event Description
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It was to reported to boston scientific corporation that a two previously implanted percuflex plus ureteral stent was removed from the left and 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 left and right ureter, and the patient was prescribed the discharge medications acetaminophen (tylenol) and narcotic analgesics (opioids).No issues were noted with the device.On (b)(6) 2022, the patient had experienced a left and right flank pain.The patient was given tylenol, ibuprofen, urine sample, 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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Block g3: study: (b)(4) 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.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: 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.Block h11: updated b5 (describe event or problem) block b6: removed the statement "the patient had a medical history of bowel disease".And moved to block b7 (other relevant history).
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Event Description
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Note: this report pertains to the first of two devices that were used in the same procedure.It was to reported to boston scientific corporation that a two previously implanted percuflex plus ureteral stent was removed from the left and 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 left and right ureter, and the patient was prescribed the discharge medications acetaminophen (tylenol) and narcotic analgesics (opioids).No issues were noted with the device.On (b)(6) 2022, the patient had experienced a left and right flank pain.The patient was given tylenol, ibuprofen, urine sample, 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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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 b3, block b5 and block d6a have been updated based on additional information received (b)(6) 2022, and (b)(6) 2022.
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Event Description
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Note: this report pertains to the first of two devices that were used in the same procedure.It was to reported to boston scientific corporation that a two previously implanted percuflex plus ureteral stent was removed from the left and 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 left and right ureter, and the patient was prescribed the discharge medications acetaminophen (tylenol) and narcotic analgesics (opioids).No issues were noted with the device.On (b)(6), 2022, the patient had experienced a left and right flank pain.The patient was given tylenol, ibuprofen, urine sample, 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 received that the onset date was on (b)(6) 2022, and the stop date was on (b)(6) 2022.As per company assessment comment that based upon medical review assessment, the data reasonably suggest the clinical event moderate bilateral flank pain, requiring medication, and assessed as probably related to the procedure and device, and not related to stent removal.
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Search Alerts/Recalls
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