MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CS-25703-E
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the guide wire could get not through the ars." the user changed to a new set to complete the procedure.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the guide wire could get not through the ars." the user changed to a new set to complete the procedure.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one guide wire with lidstock for analysis.The arrow raulerson syringe (ars) was not returned for evaluation.Signs of use, in the form of biological material, were observed on the guidewire tubing.Visual inspection identified two kinks in the guidewire.The distal j-bend was slightly misshapen, and one offset coil was observed in the j-bend region.One of the kinks was located adjacent to the j-bend.Microscopic examination confirmed the damage and revealed that the distal and proximal welds were secure and intact.The overall length of the guidewire measured 600mm, which is within the specification limits of 596mm-604mm per the guidewire product drawing.The outer diameter of the guidewire measured 0.796mm, which is within the specification limits of 0.788mm-0.826mm per the guidewire product drawing.The guidewire was functionally tested in accordance with the product instructions for use (ifu).The ifu provided with this kit instructs the user to "advance the guidewire into the arrow raulerson syringe approximately 10 cm until it passes through the syringe valves or into the introducer needle." functional testing was performed by advancing the guidewire through a laboratory inventory arrow raulerson syringe (ars) and a laboratory inventory 18-gauge introducer needle.Minor resistance was observed at the kinked locations; however, the undamaged portions of the guidewire advanced through the ars and introducer needle without resistance.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed, and no relevant findings were identified.The 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 report of a kinked guidewire was confirmed through investigation of the returned sample.Visual inspection identified two kinks in the guidewire.The distal j-bend was slightly misshapen, and one offset coil was observed in the j-bend region.One of the kinks was located adjacent to the j-bend.The returned guide wire met all relevant dimensional and functional requirements, and a device history record review did not identify any manufacturing-related issues.Based on the customer report and the sample received, the failure appears consistent with damage due to undue force applied during insertion; however , without the ars also returned for analysis, the root cause cannot be determined at this time.Teleflex will continue to monitor and trend for reports.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24546171
• Report Number: 3006425876-2026-00341
• Device Sequence Number: 21176534
• Product Code: FOZ
• UDI-Device Identifier: 00801902102324
• UDI-Public: (01)00801902102324(11)250306(17)270213(10)71F25B1135(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K900263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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: CS-25703-E
• Device Lot Number: 71F25B1135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2025
• 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