Model Number M0061453520 |
Device Problem
Break (1069)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/23/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
H6: imdrf device code a0401 captures the reportable event of stent shaft break.
|
|
Event Description
|
It was reported to boston scientific corporation that a percuflex ureteral stent was used during a ureteral stricture procedure performed on (b)(6) 2024.During unpacking, the stent was found broken.The procedure was successfully completed with another percuflex ureteral stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was stable.
|
|
Manufacturer Narrative
|
Block h6: imdrf device code a0401 captures the reportable event of stent shaft break.Block h10: updated field block b1: initial reporter address 2.Correction to field e1: initial reporter address 1.Additional information was received from the complainant on (b)(6) 2024, the percuflex stent coil was clarified to be detached, occurred outside the patient.The manufacturer has reviewed all information and determined this event no longer meets reporting criteria.This event is now considered non reportable.The event reported under mfr report number 2124215-2024-19179 was sent in error.
|
|
Event Description
|
It was reported to boston scientific corporation that a percuflex ureteral stent was used during a ureteral stricture procedure performed on (b)(6) 2024.During unpacking, the stent was found broken.The procedure was successfully completed with another percuflex ureteral stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was stable.
|
|
Search Alerts/Recalls
|