PERCUFLEX PLUS
Received Jul 8, 2026 · Event occurred Jun 9, 2026
Report 2124215-2026-36566 · MDR key 25749406
Device
Generic name
Catheter, Biliary, Diagnostic
Manufacturer
Boston Scientific CorporationModel number
M0061752530Catalog number
175-253
Lot number
0037237781
Product problems
- Break
- Detachment of Device or Device Component
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK E1: INITIAL REPORTER ADDRESS 1: (B)(6). BLOCK H6: DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF STENT SHAFT BREAK.
Description of Event or Problem
IT WAS REPORTED THAT A PERCUFLEX PLUS WAS TO BE USED IN A URETERAL STENT IMPLANTATION PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS FRACTURED IN THREE PARTS IN THE MIDDLE AND THE COIL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE.