C.R. BARD, INC. (COVINGTON) -1018233 BARD® INLAY OPTIMA® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE
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Model Number 787830 |
Device Problem
Calcified (1077)
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Patient Problem
Urethral Stenosis/Stricture (4501)
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Event Date 04/17/2023 |
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.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.H3 other text : the device was not returned.
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Event Description
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It was reported that a physician stated in an online survey that the patient experienced stone formation, extravasation, fistula formation, pain or discomfort, hydronephrosis prior to the device placement and stone formation, ureteral reflux, stent dislodgement complications were directly attributable to the device and ureteral stricture was needed for stone formation in relation to inlay optima ureteral stent with hydroglide guidewire, 8.0 fr.X 30cm.
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Manufacturer Narrative
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The reported event is inconclusive because no sample was returned for evaluation and further investigation was not conclusive.The device was used for treatment purposes.It is unknown if the device had met all relevant specifications or resulted in the reported failure.Though a specific cause cannot be determined, a potential root cause for this event could be material selection.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: "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.H3 other text : the device was not returned.
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Event Description
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It was reported that a physician stated in an online survey that the patient experienced stone formation, extravasation, fistula formation, pain or discomfort, hydronephrosis prior to the device placement and stone formation, ureteral reflux, stent dislodgement complications were directly attributable to the device and ureteral stricture was needed for stone formation in relation to inlay optima ureteral stent with hydroglide guidewire, 8.0 fr.X 30cm.
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