MAUDE Adverse Event Report: Arrow International LLC ARROW RA CATH SET: 20 GA X 1-1/2 IN; WIRE GUIDE CATHETER

Catalog Number	RA-04220
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during ultrasound-guided insertion of a radial arterial catheter in a patient with significant vascular disease, blood flashback was obtained and the guidewire, sheath, and needle were advanced.The clinician subsequently encountered significant resistance while attempting to remove the needle and was also unable to retract the guidewire or remove the device intact.A vascular specialist was consulted and removed the device using force while the patient remained under general anesthesia.Examination of the returned device identified a 90-degree bend in the cannula and guidewire approximately 10 mm from the distal end and a break with distortion in the cannula approximately 15 mm from the proximal end.It was reported that the distortion may have been caused by the force required during device removal.The procedure was completed following device removal.No patient injury or adverse health consequences were reported.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: ARROW RA CATH SET: 20 GA X 1-1/2 IN
• Common Device Name: WIRE GUIDE CATHETER
• Manufacturer (Section D): Arrow International LLC; morrisville NC
• Manufacturer (Section G): Arrow International de Mexico S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 50186774
• Report Number: 9680794-2026-00573
• Device Sequence Number: 10193952
• Product Code: OFB
• UDI-Device Identifier: 10801902210637
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: RA-04220
• Device Lot Number: 14F25A0324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2026
• Supplement Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 08/08/2026
• Supplement Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: None reported
• Patient Sex: Unknown