MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH SET:18 GA CATH/20 GA NDL; WIRE GUIDE CATHETER

Catalog Number	FA-04018
Medical Device Problem Codes	Material Separation (1562); Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during an attempted placement of a 20-gauge arterial integrated guidewire catheter system in the left femoral artery under ultrasound guidance, resistance was encountered after partial insertion of the device, and further advancement was immediately discontinued.Subsequent attempts to withdraw the device were met with persistent resistance.During careful traction, the spring wire guide (swg) reportedly deformed and sheared, resulting in retention of a wire segment within the arterial vessel.Bedside ultrasound demonstrated an echogenic linear structure within the wall of the left femoral artery, consistent with a retained guidewire segment, which appeared to be adjacent to the tunica media.No immediate evidence of active extravasation, pseudoaneurysm, or expanding hematoma was observed.Further manipulation of the device was ceased immediately.The external portion of the wire was secured with hemostats to prevent migration.Hemostasis was maintained, and the insertion site was covered with a sterile dressing and a chlorhexidine gluconate (chg) impregnated protective disk dressing.The patient was subsequently transferred to interventional radiology for removal of the retained swg segment.It was also reported that a new arterial catheter was successfully placed.It was also reported that the patient subsequently expired due to sepsis associated with a pre-existing permanent catheter.The sepsis infection was reported to have been present prior to the reported event and was the reason for the patient's emergency department admission.

• Brand Name: ARROW ARTERIAL CATH SET:18 GA CATH/20 GA NDL
• 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: 25706730
• Report Number: 9680794-2026-00493
• Device Sequence Number: 21482278
• Product Code: OFB
• UDI-Device Identifier: 10801902203004
• UDI-Public: (01)10801902203004(11)240522(17)290430(10)13F24E0010
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2026

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: FA-04018
• Device Lot Number: 13F24E0010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2026
• Supplement Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 07/03/2026
• Supplement Report FDA Received Date: 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2024
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown