ARROW RA CATH SET: 20 GA X 1-3/4IN
Received Apr 7, 2026 · Event occurred Dec 18, 2025
Report 9680794-2026-00255 · MDR key 24801341
Device
Generic name
Wire Guide Catheter
Manufacturer
Arrow International LlcCatalog number
RA-04020
Lot number
14F19M0253
Product problems
- Material Twisted/Bent
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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.
Additional Manufacturer Narrative
(B)(4).
Additional Manufacturer Narrative
QN #: (B)(4). UPON INITIAL TRIAGE OF THE RETURNED SAMPLE, IT WAS FOUND THAT THE MALFUNCTION WAS NOT REPORTABLE; THUS THE INITIAL MDR, SUBMITTED ON 07-APR-2026, SHOULD BE RETRACTED.
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.