PERCUFLEX PLUS
Received May 22, 2026 · Event occurred Apr 20, 2026
Report 2124215-2026-27767 · MDR key 25258452
Device
Generic name
Catheter, Biliary, Diagnostic
Manufacturer
Boston Scientific CorporationModel number
M0061752530Catalog number
175-253
Lot number
0036786326
Product problems
- Difficult to Advance
- Material Deformation
Patient
79 YR · Male
- 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 RIGHT URETERAL STENT INSERTION VIA URETEROSCOPY PROCEDURE DUE TO RIGHT URETERAL CALCULUS WITH HYDRONEPHROSIS. DURING THE PROCEDURE, THE INSERTION WAS UNSUCCESSFUL AND THE STENT WAS REMOVED USING A PAIR FORCEPS, CAUSING PROLONGED SURGERY. IT WAS NOTICED THAT THE STENT WAS KINKED UPON CONTACT WITH THE STONE N THE URETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER URETERAL STENT AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Additional Manufacturer Narrative
BLOCK H6: DEVICE CODE A0406 CAPTURES THE REPORTABLE EVENT OF STENT KINKED INSIDE THE PATIENT. IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF THE USE OF BIOPSY FORCEPS TO RETRIEVE THE STENT.