MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW SPRING WIRE GUIDE COMPONENT; CATHETER HEMODIALYSIS IMPLANTE

Catalog Number	AW-04435
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the guide wire bent".The user changed to a new set to complete the procedure.There was no patient harm or injury.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one kinked guidewire for analysis.Signs of use were observed on the guidewire.Visual inspection identified one kink in the guidewire, towards distal end.The distal j-bend was misshapen.Microscopic examination confirmed the observed kinks.Both the distal and proximal welds were present and appeared full and spherical.One kink on the guide wire located at 480mm from the proximal weld.The overall length of the guide wire measured 599mm, which is within the specification of 596mm-604mm per product drawing.The outer diameter of the guide wire measured 0.857mm, which is within the specification of 0.838-0.877mm per guide wire product drawing.Functional inspection of the guidewire was performed with reference to the instructions for use (ifu) provided with the kit which states: "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the returned guidewire was advanced through a laboratory inventory arrow raulerson syringe (ars)/18 ga introducer needle subassembly.Minor resistance was encountered at a kinked location of the guidewire.All undamaged sections of the guidewire passed through the ars/18 ga introducer needle subassembly without resistance.A manual tug test confirmed the distal and proximal welds were secure and intact.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use.The instructions caution, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested." the customer-reported guidewire kink observed during use was confirmed through investigation of the returned sample.Visual inspection identified one kink in the guidewire towards the distal end.The distal j bend was misshapen.The returned guide wire met all relevant dimensional requirements; however, minor resistance was encountered at the kinked 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 "the guide wire bent".The user changed to a new set to complete the procedure.There was no patient harm or injury.The patient's current condition is reported as "fine".

• Brand Name: ARROW SPRING WIRE GUIDE COMPONENT
• Common Device Name: CATHETER HEMODIALYSIS IMPLANTE
• 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: 24815245
• Report Number: 9680794-2026-00273
• Device Sequence Number: 14959240
• Product Code: PPO
• UDI-Device Identifier: 10801902122503
• UDI-Public: (01)10801902122503(11)250507(17)300430(10)14F25C0230(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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
• Device Catalogue Number: AW-04435
• Device Lot Number: 14F25C0230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2025
• 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