C.R. BARD, INC. (COVINGTON) -1018233 BARD® INLAY OPTIMA® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE
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Model Number 787830 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/17/2023 |
Event Type
malfunction
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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 investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.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.Though a specific cause cannot be determined, a potential root cause for this event could be material selection or part geometry.The device was used for treatment purposes.It was unknown if the device had met all relevant specifications or resulted in the reported failure.A dhr review cannot be completed as the lot number is unknown.The instructions for use were found adequate and state the following: "with any ureteral stent, migration is a possible complication, which could require medical intervention for removal.Selection of too short a stent may result in migration." "the insertion of a ureteral stent should only be done by those individuals who have comprehensive training in the techniques and risks of the procedure." 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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