ARROW RA CATH KIT: 20 GA X 1-3/4IN
Received Mar 17, 2026 · Event occurred Feb 22, 2026
Report 9680794-2026-00192 · MDR key 24616972
Device
Generic name
Wire Guide Catheter
Manufacturer
Arrow International LlcCatalog number
AK-04020-C
Lot number
33F25D0169
Product problems
- Unintended Movement
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4). THE CUSTOMER REPORT OF A KINKED GUIDE WIRE DUE TO NEEDLE RESISTANCE WAS CONFIRMED BY VISUAL INSPECTION OF THE CUSTOMER SUPPLIED PHOTO. HOWEVER, FULL COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE, 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 THAT "GUIDEWIRE POPPED OUT OF THE SIDE OF THE CASING INSTEAD OF THE NEEDLE." THIS EVENT HAPPENED TWICE. THE THIRD ATTEMPT WAS SUCCESSFUL. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2026-00192 AND 9680794-2026-00196.
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
IT WAS REPORTED THAT "GUIDEWIRE POPPED OUT OF THE SIDE OF THE CASING INSTEAD OF THE NEEDLE." THIS EVENT HAPPENED TWICE. THE THIRD ATTEMPT WAS SUCCESSFUL. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2026-00196.