ARROW RA CATH KIT: 20 GA X 4.45 CM
Received Jun 16, 2026 · Event occurred May 22, 2026
Report 9680794-2026-00460 · MDR key 25520186
Device
Generic name
Wire, Guide, Catheter
Manufacturer
Arrow International LlcCatalog number
NA-04020-X1A
Lot number
UNKNOWN
Product problems
- Unraveled Material
- Insufficient Device Problem Information
Patient
NA · Unknown
- Insufficient Information
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
IT WAS REPORTED THAT ON (B)(6) 2026, DURING INITIAL INSERTION OF AN ARTERIAL CATHETER, THE SPRING WIRE GUIDE (SWG) WAS OBSERVED TO BE UNRAVELED UPON REMOVAL. GOOD FAITH EFFORTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED DEVICE ISSUE AND TO ASSESS WHETHER ANY PATIENT HARM, INJURY, OR ADVERSE HEALTH CONSEQUENCES OCCURRED. A TOTAL OF THREE DOCUMENTED ATTEMPTS WERE MADE TO CONTACT THE USER FACILITY; HOWEVER, NO RESPONSE OR ADDITIONAL INFORMATION WAS RECEIVED. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.