MalfunctionFAD
PERCUFLEX? PLUS
Received Apr 22, 2026 · Event occurred Mar 25, 2026
Report 2124215-2026-21749 · MDR key 24955488
Device
Generic name
Catheter, Biliary, Diagnostic
Manufacturer
Boston Scientific CorporationModel number
M0061752630Catalog number
M0061752630
Lot number
0037824149
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK H6: IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF STENT SHAFT BREAK.
Description of Event or Problem
IT WAS REPORTED THAT DURING A PROCEDURE, A PERCUFLEX URETERAL STENT WAS TO BE USED. WHEN THE DEVICE WAS OPENED, IT WAS NOTICED THAT THE STENT WAS BROKEN. ANOTHER STENT WAS OPENED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.