MalfunctionFAD
PERCUFLEX
Received Jul 13, 2026 · Event occurred Jun 18, 2026
Report 2124215-2026-37424 · MDR key 25803746
Device
Generic name
Catheter, Biliary, Diagnostic
Manufacturer
Boston Scientific CorporationModel number
M0061453520Catalog number
145-352
Lot number
0037104303
Product problems
- Deformation Due to Compressive Stress
Patient
60 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK H6: DEVICE CODE A040601 CAPTURES THE REPORTABLE EVENT OF STENT BUCKLED MATERIAL INSIDE THE PATIENT.
Description of Event or Problem
IT WAS REPORTED THAT A PERCUFLEX URETERAL STENT WAS USED IN A LITHOTRIPSY FOR LEFT RENAL CALCULI PROCEDURE IN THE LEFT KIDNEY. DURING INSERTION, AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE PIGTAIL AT THE BLADDER END WAS WRINKLED AND COULD NOT BE PLACED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.