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Model Number 778626 |
Device Problem
Calcified (1077)
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Patient Problems
Calcium Deposits/Calcification (1758); 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, ureteral reflux, stent dislodgement, migration, stent encrustation, pain and discomfort while using the bard 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".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." "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 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.
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Event Description
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It was reported that the patient experienced edema, ureteral reflux, stent dislodgement, migration, stent encrustation, pain and discomfort while using the bard ureteral stent.No medical intervention was reported.
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Search Alerts/Recalls
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