MalfunctionOFB
ARROW RA CATH SET: 22 GA X 1-3/8IN
Received Apr 7, 2026 · Event occurred Mar 13, 2026
Report 9680794-2026-00254 · MDR key 24801491
Device
Generic name
Wire Guide Catheter
Manufacturer
Arrow International LlcCatalog number
RA-04122
Lot number
UNKNOWN
Product problems
- Material Twisted/Bent
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
IT WAS REPORTED THAT "THE WIRE WAS FOUND KINKED." THE DEVICE WAS CONSIDERED UNUSABLE AND WAS REPLACED WITH A NEW DEVICE. THIS WAS FOUND PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.