MalfunctionFAD
PERCUFLEX? PLUS
Received Apr 20, 2026 · Event occurred Feb 24, 2026
Report 2124215-2026-21393 · MDR key 24933388
Device
Generic name
Catheter, Biliary, Diagnostic
Manufacturer
Boston Scientific CorporationModel number
M0061752740Catalog number
M0061752740
Lot number
0034716895
Product problems
- Break
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS USED IN A DOUBLE J INSERTION PROCEDURE. DURING THE PROCEDURE, IT WAS NOTICED THAT THE STENT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Additional Manufacturer Narrative
BLOCK H6: DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF STENT SHAFT BREAK.