inforMED
MalfunctionPDU

CROSSER IQ

Received Sep 15, 2025 · Event occurred Jul 26, 2025

Report 23050676 · MDR key 23050676

Device

Generic name

Catheter For Crossing Total Occlusions

Model number

XCTO146

Catalog number

XCTO146

Lot number

GFKR1647

Product problems

  • Break
  • Entrapment of Device

Patient

1 MO · Female

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

A PART OF THE CATHETER BROKE OFF. THE FOREIGN OBJECT WAS RETRIEVED FROM THE TIBIAL TRUNK WITH A SNARE DEVICE. NO COMPLICATION WAS IDENTIFIED. BD VENDOR HAS BEEN NOTIFIED OF CATHETER INCIDENT. WILL WORK WITH VENDOR TO INVESTIGATE THE MALFUNCTION OF THE ATHERECTOMY CATHETER AND REPORT BACK TO BD. MANUFACTURER RESPONSE FOR ATHERECTOMY DEVICE, BD CROSSER (PER SITE REPORTER). BD VENDOR HAS BEEN NOTIFIED OF CATHETER INCIDENT. WILL WORK WITH VENDOR TO INVESTIGATE THE MALFUNCTION OF THE ATHERECTOMY CATHETER AND REPORT BACK TO BD.