|
Model Number 778600 |
Device Problems
Biocompatibility (2886); Patient Device Interaction Problem (4001)
|
Patient Problem
Extravasation (1842)
|
Event Date 09/29/2021 |
Event Type
Injury
|
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 mentioned the following complications including stone formation, extravasation , ureteral reflux , stent dislodgement and migration, occlusion, pain/discomfort , stent encrustation, perforation of kidney, renal pelvis, ureter and/or bladder , ureteral erosion, infection, urinary symptoms while using the ureteral stent.Medical intervention was unknown.
|
|
Manufacturer Narrative
|
The reported event is inconclusive since no sample was returned.A potential root cause for this event could be, "material selection" or "part geometry".The device was used for treatment purposes, however, it is unknown if the device had met relevant specifications or contributed to the reported event.A dhr review is not required as the lot number is unknown.Based on the results of the investigation no additional action is required at this time.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 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" "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." "for single use only.Do not resterilize.Do not use if the package or product is damaged." 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 mentioned the following complications including stone formation, extravasation , ureteral reflux , stent dislodgement and migration, occlusion, pain/discomfort , stent encrustation, perforation of kidney, renal pelvis, ureter and/or bladder , ureteral erosion, infection, urinary symptoms while using the ureteral stent.It was unknown what medical intervention was provided.
|
|
Search Alerts/Recalls
|
|
|