MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 12 FR X 16 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CS-22123-F
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "on (b)(6) 2025, during insertion the doctor found the swg tip kinked during to the patient.The swg can't be inserted into ars." the user changed to a new set to resolve the issue.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).
Additional Manufacturer Narrative
(b)(4) the customer returned one guidewire assembly for analysis.The arrow raulerson syringe (ars) and 18ga introducer needle were not returned.Signs of use in the form of biological material were observed inside the guidewire tubing.Visual examination of the guidewire revealed one kink.This kink resulted in the j-bend being slightly misshapen.Microscopic examination confirmed the damage and revealed that the distal and proximal welds were secure and intact.Visual analysis could not be performed on the ars/18ga introducer needle subassembly, as they were not returned.The kink on the guidewire measured 571mm from the proximal weld.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 0.84mm , which is within the specification limits of 0.838mm - 0.877mm per the guidewire product drawing.Functional testing was performed per the instructions for use (ifu) provided with this kit.The ifu states , "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".The guidewire was inserted into a lab inventory ars/18ga introducer needle subassembly.Resistance was encountered at the location of the kinking.However, the undamaged portion of the guidewire was able to pass with no issue.Functional analysis could not be performed on the actual ars/introducer needle involved with this complaint, as they were not returned.A manual tug test confirmed that both guidewire welds were secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The ifu also states, "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 analysis of the guidewire revealed that it was kinked.Despite this, the guidewire passed all relevant dimensional and functional requirements.A device history record review was performed, and no relevant findings were identified.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.
Event or Problem Description
It was reported that " on (b)(6) 2025, during insertion the doctor found the swg tip kinked during to the patient.The swg can't be inserted into ars." the user changed to a new set to resolve the issue.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW CVC SET: 3-LUMEN 12 FR X 16 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: 23199274
• Report Number: 3006425876-2025-00897
• Device Sequence Number: 9139666
• Product Code: FOZ
• UDI-Device Identifier: 00801902102188
• UDI-Public: (01)00801902102188(11)240703(17)260513(10)71F24F1171(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K900263
• 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): 09/08/2025

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 Expiration Date: 05/13/2026
• Device Catalogue Number: CS-22123-F
• Device Lot Number: 71F24F1171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2024
• 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; NOT REPORTED
• Patient Sex: Unknown