C.R. BARD, INC. (COVINGTON) -1018233 BARD® INLAY® URETERAL STENT WITH NICORE¿ GUIDEWIRE
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Model Number 776724 |
Device Problem
Partial Blockage (1065)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/06/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
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Event Description
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It was reported that the patient experienced edema, stone formation, extravasation, ureteral reflux, stent dislodgement, migration, fragmentation, occlusion, fistula formation, loss of renal function, hemorrhage, stent encrustation, hydronephrosis, perforation of kidney, renal pelvis, ureter and bladder, ureteral erosion, infection, pain and discomfort while using the ureteral stent.No medical intervention was reported.
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Manufacturer Narrative
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The reported event is inconclusive because no sample was returned.A potential root cause for this event could be, "material selection" or "part geometry".The device was used for treatment purposes, however, it is unknown if the device had met relevant specifications or contributed to the reported event.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "potential complications associated with retrograde/antegrade positioning of indwelling ureteral stents include the following: ¿ edema ¿ stone formation ¿ peritonitis ¿ extravasation ¿ ureteral reflux ¿ stent dislogdgement, fragmentation, migration, occlusion ¿ fistula formation ¿ loss of renal function ¿ hemorrhage ¿ pain/discomfort ¿ stent encrustation ¿ hydronephrosis ¿ perforation of kidney, renal pelvis, ureter and/or bladder ¿ ureteral erosion ¿ infection ¿ urinary symptoms" "determine the proper stent length for the patient.This is generally calculated from the baseline pyelogram.Accurate measurements will optimize drainage efficiency and patient comfort.Submerge stent in sterile water to activate the coating." h11: section a through f - the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.H3 other text : the device was not returned.
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Event Description
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It was reported that the patient experienced edema, stone formation, extravasation, ureteral reflux, stent dislodgement, migration, fragmentation, occlusion, fistula formation, loss of renal function, hemorrhage, stent encrustation, hydronephrosis, perforation of kidney, renal pelvis, ureter and bladder, ureteral erosion, infection, pain and discomfort while using the ureteral stent.
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