|
Model Number 788600 |
Device Problem
Calcified (1077)
|
Patient Problem
Calcium Deposits/Calcification (1758)
|
Event Date 11/03/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
|
|
Event Description
|
It was reported that the user experienced edema, ureteral reflux, pain/discomfort, hydronephrosis, infection, urinary symptoms.Stone formation, stent dislodgement, migration, occlusion, stent encrustation while using the ureteral stent.No medical intervention was reported.
|
|
Manufacturer Narrative
|
The reported event was inconclusive.No sample was returned for evaluation.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 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 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 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.
|
|
Event Description
|
It was reported that the user experienced edema, ureteral reflux, pain/discomfort, hydronephrosis, infection, urinary symptoms.Stone formation, stent dislodgement, migration, occlusion, stent encrustation while using the ureteral stent.No medical intervention was reported.
|
|
Search Alerts/Recalls
|
|
|