inforMED
MalfunctionOFB

ARROW RA CATH SET: 20 GA X 1-1/2 IN

Received Apr 2, 2026 · Event occurred Feb 10, 2026

Report 9680794-2026-00222 · MDR key 24766650

Device

Generic name

Wire Guide Catheter

Catalog number

RA-04220

Lot number

UNKNOWN

Product problems

  • Material Twisted/Bent

Patient

NA · Unknown

  • Insufficient Information

Narrative

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED "AFTER INSERTION THE ART LINE AND USING THE WIRE, THE CANNULA WOULDN'T PUSH OFF THE NEEDLE/WIRE EVEN THOUGH CLEARLY IN THE ARTERY. EVENTUALLY THE CLINICIAN REMOVED TO FIND THE WIRE BENT. CLINICIAN ATTEMPTED ANOTHER INSERTION WITH THE SAME ART LINE AND THE SAME THING OCCURRED. THE CLINICIAN THEN USED A PINK ANIO CATH WITH NO PROBLEMS." THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME. ASSOCIATE MDR NUMBERS INCLUDE:9680794-2026-00214 AND .

Additional Manufacturer Narrative

(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

Description of Event or Problem

IT WAS REPORTED "FTER INSERTION THE ART LINE AND USING THE WIRE, THE CANNULA WOULDNT PUSH OFF THE NEEDLE/WIRE EVEN THOUGH CLEARLY IN THE ARTERY. EVENTUALLY THE CLINICIAN REMOVED TO FIND THE WIRE BENT. CLINICIAN ATTEMPTED ANOTHER INSERTION WITH THE SAME ART LINE AND THE SAME THING OCCURRED. THE CLINICIAN THEN USED A PINK ANIO CATH WITH NO PROBLEMS." THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME. ASSOCIATE MDR NUMBERS INCLUDE:9680794-2026-00214 AND 9680794-2026-00222.