inforMED
MalfunctionDQY

EXCELSIOR XT-17 STD STRAIGHT 150CM

Received Jun 4, 2026 · Event occurred Mar 19, 2026

Report 3008881809-2026-00349 · MDR key 25398247

Device

Generic name

Catheter, Percutaneous

Catalog number

M003C1775ST0

Lot number

25865985

Product problems

  • Material Puncture/Hole

Patient

57 YR · Female

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THE MICROCATHETER (SUBJECT DEVICE) WAS RETURNED WITH THE ATLAS STENT DEVICE AND THE VISUAL/MICROSCOPIC INSPECTION REVEALED THAT THE SDW (STENT DELIVERY WIRE) OF THE ATLAS STENT HAD PIERCED THROUGH THE LUMEN/SHAFT OF THE SUBJECT MICROCATHETER. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

Additional Manufacturer Narrative

THIS IS 2 OF 2 MDRS.