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
Manufacturer
Teleflex Llc. (nadc 2)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.