PERCUFLEX PLUS
Received Apr 9, 2026 · Event occurred Mar 10, 2026
Report 2124215-2026-19250 · MDR key 24837969
Device
Generic name
Catheter, Biliary, Diagnostic
Manufacturer
Boston Scientific CorporationModel number
M0061752520Catalog number
175-252
Lot number
0037265701
Product problems
- Detachment of Device or Device Component
Patient
55 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 URETEROSCOPIC INTERVENTION PROCEDURE IN THE URETER. DURING PROCEDURE CLOSURE, IT WAS NOTICED THAT THE FRONT END OF THE STENT WAS FRACTURED BUT DID NOT FALL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE COIL WAS DETACHED.
Additional Manufacturer Narrative
BLOCK H6: DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF COIL DETACHED INSIDE THE PATIENT.