Model Number M0061752630 |
Device Problems
Calcified (1077); Difficult to Remove (1528); Use of Device Problem (1670)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/01/2023 |
Event Type
Injury
|
Event Description
|
It was reported to boston scientific corporation that a percuflex plus ureteral stent was successfully implanted during a procedure.The event date was unknown.After four months of being implanted, it was noted that the stent was encrusted.It was mentioned that it took a long duration of intervention.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
|
|
Manufacturer Narrative
|
Block b3: date of event was approximated to (b)(6) 2023 based on the date the manufacturer became aware of the event.Block e1: initial reporter city: ried im innkreis, oberosterreich block h6: imdrf device code a150207 captures the reportable event of stent difficult to remove.Imdrf device code a040501 captures the reportable event of stent calcified.
|
|
Event Description
|
It was reported to boston scientific corporation that a percuflex plus ureteral stent was successfully implanted during a procedure.The event date was unknown.After four months of being implanted, it was noted that the stent was encrusted.It was mentioned that it took a long duration of intervention.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.Additional information received that the problem happened with a timespan within the last six months.
|
|
Manufacturer Narrative
|
Block b3: date of event was approximated to november 1, 2023 based on the date the manufacturer became aware of the event.Block e1: initial reporter city: ried im innkreis, oberosterreich block h6: imdrf device code a150207 captures the reportable event of stent difficult to remove.Imdrf device code a040501 captures the reportable event of stent calcified.Update to block b5: additional information received on 01dec2023, that the problem happened with a timespan within the last six months.
|
|
Manufacturer Narrative
|
Block b3: date of event was approximated to (b)(6) 2023 based on the date the manufacturer became aware of the event.Block e1: initial reporter city: (b)(6).Block h6: imdrf device code a150207 captures the reportable event of stent difficult to remove.Imdrf device code a040501 captures the reportable event of stent calcified.Update to block b5: additional information received on 01dec2023, that the problem happened with a timespan within the last six months.Block h10: the returned percuflex plus ureteral stent was analyzed, and a visual and microscopic evaluation noted that both coils and the shaft were calcified.Additionally, the suture and positioner were not returned.The patient or impact codes reported are a condition that could not be tested, analyzed or replicated on the product analysis laboratory; therefore, those events are not confirmed.The reported event of stent calcified and stent difficult to remove are confirmed.Taking all available information into consideration, due to the calcified stent, it is possible to confirm the difficult to removed reported by the customer.Regarding the use of device issue-misuse, due to information provided, it can be concluded that the device was intentionally indwelling past 90 days without evaluation resulting in an encrustation of the stent and difficult removal.Therefore, all compiled information on this investigation determines that the most probable cause is failure to follow instructions since problems traced to the user not following the manufacturer's instructions.
|
|
Event Description
|
It was reported to boston scientific corporation that a percuflex plus ureteral stent was successfully implanted during a procedure.The event date was unknown.After four months of being implanted, it was noted that the stent was encrusted.It was mentioned that it took a long duration of intervention.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.Additional information received that the problem happened with a timespan within the last six months.
|
|
Search Alerts/Recalls
|