|
Catalog Number 788426 |
Device Problem
Material Fragmentation (1261)
|
Patient Problem
Foreign Body In Patient (2687)
|
Event Date 12/05/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
|
|
Event Description
|
It was reported that the patient underwent right ureteral stent replacement in the operating theatre, and during extraction of the ureteral stent, the right ureteral stent broke and remained at the pelvic end of the kidney due to a stone at the pelvic end that could not be removed during extraction.It was unknown what medical intervention was provided.
|
|
Manufacturer Narrative
|
The reported event is inconclusive as no sample was returned for evaluation.Although an exact root cause could not be determined a potential root cause could be material selection.The dhr review did not show any problems or conditions that would have contributed to the reported event.The instructions for use were found adequate and states the following: "avoid improper handling of stent such as bending, kinking, tearing, etc.Misuse could damage the overall integrity of the stent." "care should be exercised when removing the stent from inner polybag so as not to cause tearing or fragmentation." "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." correction- b, e 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.
|
|
Event Description
|
It was reported that the patient underwent right ureteral stent replacement in the operating theatre, and during extraction of the ureteral stent, the right ureteral stent broke and remained at the pelvic end of the kidney due to a stone at the pelvic end that could not be removed during extraction.
|
|
Search Alerts/Recalls
|
|
|