C.R. BARD, INC. (COVINGTON) -1018233 BARD® INLAY OPTIMA® URETERAL STENT WITH NICORE¿ GUIDEWIRE
|
Back to Search Results |
|
Model Number 786626 |
Device Problems
Biocompatibility (2886); Patient Device Interaction Problem (4001)
|
Patient Problems
Pain (1994); Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 10/08/2021 |
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 patient experienced stone formation, ureteral reflux, pain and discomfort, stent encrustation and urinary symptoms using urethral stents.Unknown what medical intervention was provided for ureteral reflux.
|
|
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.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"."determine the proper stent length for the patient.This is generally calculated from the baseline pyelogram.Accurate measurements will optimize drainage efficiency and patient comfort." "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 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.
|
|
Event Description
|
It was reported that the patient experienced stone formation ,ureteral reflux , pain and discomfort, stent encrustation and urinary symptoms while using urethral stents.Medical intervention was unknown.
|
|
Search Alerts/Recalls
|
|
|