MalfunctionOFB
ARROW RA CATH SET: 22 GA X 1-3/8IN
Received Jul 7, 2026 · Event occurred Jun 9, 2026
Report 9680794-2026-00507 · MDR key 25733973
Device
Generic name
Wire Guide Catheter
Manufacturer
Arrow International LlcCatalog number
RA-04122
Lot number
14F25G0154
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 DURING INITIAL INSERTION OF AN ARTERIAL CATHETER, THE SPRING WIRE GUIDE (SWG) WAS OBSERVED TO BE KINKED. THE AFFECTED DEVICE WAS REMOVED AND REPLACED WITH ANOTHER DEVICE. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.