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

Catalog Number	RA-04220-W
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2026
Type of Reportable Event	Malfunction

• Brand Name: ARROW RA CATH SET: 20 GA X 1 1/2IN
• 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: 50812477
• Report Number: 9680794-2026-00671
• Device Sequence Number: 21494639
• Product Code: OFB
• UDI-Device Identifier: 10801902202984
• UDI-Public: (01)10801902202984(11)250123(17)291231(10)13F25A0008
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 08/20/2026

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-W
• Device Lot Number: 13F25A0008
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 09/17/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2025
• 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
• Patient Sex: Unknown