MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATHETER KIT: 18 GA X 16 CM; WIRE, GUIDE, CATHETER

Catalog Number	ASK-04018-UPM
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "guidewire issues (gripping and flexibility), kinking, and issues with insertion." the catheter was not placed due to the wire kinking.There was a delay in care.The patient's current condition is unknown at this time.
Additional Manufacturer Narrative
(b)(4).The customer-reported guidewire kink observed during use was confirmed through investigation of the returned sample.Visual examination identified three kinks, one near the center of the guidewire body and two kinks towards the proximal end.The distal j-bend was misshapen but remained intact.Signs of use were observed on the returned guidewire.The returned guide wire met all relevant dimensional requirements; however, resistance was encountered at one of the kinked locations, preventing further advancement of the guidewire beyond that point during functional evaluation.No manufacturing-related defects or anomalies were identified in the returned guidewire during the investigation, and a device history record review did not identify any manufacturing related issues.Based on the condition of the guide wire and the report that the damage was observed during use, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "guidewire issues (gripping and flexibility), kinking, and issues with insertion." the catheter was not placed due to the wire kinking.There was a delay in care.The patient's current condition is unknown at this time.

• Brand Name: ARROW ARTERIAL CATHETER KIT: 18 GA X 16 CM
• 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24607579
• Report Number: 9680794-2026-00186
• Device Sequence Number: 9575567
• Product Code: OFB
• UDI-Device Identifier: 50801902117644
• UDI-Public: (01)50801902117644(11)250416(17)270831(10)33F25C0742(21)
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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
• Device Catalogue Number: ASK-04018-UPM
• Device Lot Number: 33F25C0742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2025
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown