inforMED
MalfunctionOBJ

IVUS

Received Jul 30, 2025 · Event occurred Jul 24, 2025

Report MW5173542 · MDR key 22667160

Device

Generic name

Catheter, Ultrasound, Intravascular

Catalog number

014R

Lot number

0303265573

Product problems

  • Failure to Advance

Patient

45 YR · Female

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

UNABLE TO ADVANCE IVUS CATHETER THROUGH 5 FRENCH SHEATH OVER COMMAND ES (EXTRA STIFF) WIRE WITHOUT RESISTANCE. SECOND IVUS DROPPED AND ABLE TO CROSS.