C.R. BARD, INC. (COVINGTON) -1018233 BARD® INLAY® URETERAL STENT WITH NICORE¿ GUIDEWIRE
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Model Number 776624 |
Device Problems
Calcified (1077); Biocompatibility (2886)
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Patient Problems
Calcium Deposits/Calcification (1758); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/06/2021 |
Event Type
Injury
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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.
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Event Description
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It was reported that the patient experienced edema, stone formation, ureteral reflux, stent dislodgement, migration, stent encrustation, infection, pain and discomfort while using the bard ureteral stent.Medical intervention was unknown.
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Event Description
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It was reported that the patient experienced edema, stone formation, ureteral reflux, stent dislodgement, migration, stent encrustation, infection, pain and discomfort while using the bard ureteral stent.Medical intervention was unknown.
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Manufacturer Narrative
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The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this event could be, "material selection".The lot number was 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 dislodgement, 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" "ureteral stents should be checked periodically for signs of encrustation and proper function.Periodic checks of the stent by cystoscopic and/or radiographic procedures are recommended at intervals deemed to be appropriate by the physician in consideration of the individual patient¿s condition and other patient specific factors.When long-term use is indicated, it is recommended that indwelling time not exceed 365 days.The stent is not intended as a permanent indwelling device." h11: section a through f - the information provided by bd represents all 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 bd.
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