MalfunctionFAD
PERCUFLEX PLUS
Received Jun 29, 2026 · Event occurred Jun 3, 2026
Report 2124215-2026-34724 · MDR key 25661386
Device
Generic name
Catheter, Biliary, Diagnostic
Manufacturer
Boston Scientific CorporationModel number
M0061752530Catalog number
175-253
Lot number
0037374094
Product problems
- Break
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS TO BE USED IN A STONE LITHOTRIPSY PROCEDURE. DURING UNPACKING, WHEN THE SUTURE WAS PULLED FROM THE STENT, IT WAS NOTICED THAT THE STENT BROKE NEAR THE STRING END ALONG THE SHAFT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Additional Manufacturer Narrative
DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF STENT SHAFT BREAK.