MalfunctionDYB
FLEXOR
Received Jun 30, 2026 · Event occurred Apr 16, 2026
Report 25665195 · MDR key 25665195
Device
Generic name
Introducer, Catheter
Manufacturer
Cook IncorporatedModel number
G10383Catalog number
KCFW-6.0-38-40-RB-BLKN
Lot number
16946430
Patient
91 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
WHEN ATTEMPTING TO ADVANCE THE INTRODUCER SHEATH IT WAS DISCOVERED THAT THE TIP OF THE INNER DILATOR WAS COMPRESSED FROM THE PACKAGING. THE TECH HAD TO USE THE WIRE TO ADVANCE THROUGH THE OPPOSITE END OF THE INTRODUCER TO EXPAND/ENLARGE THE TIP TO ALLOW THE INTORDUCER TO SMOOTHLY ADVANCE OVER THE WIRE IN THE NORMAL FASHION. ACCORDING TO STAFF THE REP REPLACED THE DEVICE. A NEW ONE WAS USED WITHOUT ISSUES. NO PATIENT HARM.