inforMED
MalfunctionDYB

ARROWG+ARD BLUE MAC TWO LUMEN CENTRAL VENOUS ACCESS FOR USE WITH 7.5-8

Received May 20, 2025 · Event occurred May 5, 2025

Report MW5170605 · MDR key 22052280

Device

Generic name

Introducer, Catheter

Catalog number

CDC-21242-1A

Lot number

33F24HH0331

Product problems

  • Positioning Failure
  • Material Fragmentation

Patient

44 YR · Female

  • Foreign Body In Patient
  • Foreign Body In Patient

Narrative

Description of Event or Problem

GUIDE WIRE TIP FRAGMENT FOUND AFTER CENTRAL LINE PLACEMENT FAILURE. THIN LINEAR DENSITY MEASURING APPROXIMATELY 1.8 CM, PRESUMED GUIDEWIRE TIP, IS SEEN WITHIN THE RIGHT TRANSVERSE FORAMEN OF C6 EXTENDING TO THE RIGHT NEURAL FORAMINA OF C6-C7, POSSIBLY WITHIN THE RIGHT VERTEBRAL ARTERY VERSUS VERTEBRAL VENOUS PLEXUS. 2. ADDITIONAL PUNCTATE HYPERDENSITY IS NOTED IN THE SVC, POSSIBLY A GUIDEWIRE FRAGMENT. REF REPORT: MW5170606.