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 Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the initial insertion of an arterial catheter under ultrasound guidance in the radial artery, the spring wire guide (swg) was observed to be uncoiled upon removal from the catheter.There were no reports of patient injury, harm, or adverse health consequences associated with the event.The patient's condition was reported as unchanged ("status quo").The affected device was removed and replaced with a new device, and no additional medical intervention was required.It was further reported that the artery did not contain scar tissue, plaque, or other rigid anatomical structures, such as bone or muscle mass, that could have interfered with arterial placement or contributed to the reported device issue.
Additional Manufacturer Narrative
Qn#(b)(4).

• 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: 25829022
• Report Number: 9680794-2026-00522
• Device Sequence Number: 18602046
• Product Code: OFB
• UDI-Device Identifier: 10801902202984
• UDI-Public: (01)10801902202984(11)260106(17)301231(10)13F26A0002
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2026

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: 13F26A0002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2026
• Supplement Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 07/15/2026
• Supplement Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2026
• 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: NOT REPORTED.
• Patient Sex: Unknown