Catalog Number 778600 |
Device Problem
Patient Device Interaction Problem (4001)
|
Patient Problems
Pain (1994); Discomfort (2330)
|
Event Date 03/07/2024 |
Event Type
Injury
|
Event Description
|
It was reported that the patient for stent removal and exchange experienced an adverse event directly attributable to the device 778600 - inlay versafittm multi-length ureteral stent without guidewire, 6fr., 22cm32cm and the patient experienced pain, discomfort.This did resulted in the patient injury requiring medical or surgical intervention.
|
|
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.
|
|
Manufacturer Narrative
|
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to ¿material selection".A dhr review is not required as the lot number is unknown.The instructions for use were found adequate and states 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" "with any ureteral stent, migration is a possible complication which could require medical intervention for removal.Selection of too short a stent may result in migration." "determine the proper stent length for the patient.This is generally calculated from the baseline pyelogram." 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 for stent removal and exchange experienced an adverse event directly attributable to the device 778600 - inlay versafittm multi-length ureteral stent without guidewire, 6fr., 22cm32cm and the patient experienced pain, discomfort.This did resulted in the patient injury requiring medical or surgical intervention.
|
|
Search Alerts/Recalls
|
|