MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 30 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CS-24703-E
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "a cvc was to be placed.After the nurse prepared the necessary materials, the physician performed the cvc insertion under full sterile conditions and protective equipment.The insertion procedure went smoothly.However, when inserting the guidewire, difficulty was encountered.Upon removal, the guidewire was found to be deformed." another guidewire was used.There was no patient harm or injury.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer provided one image of the guidewire and the cvc packaging.The condition of the guidewire is unknown based on the customer supplied image.The customer also returned one opened cvc tray, one guidewire, and one catheter clamp.Minimal signs of use in the form of biological material were observed on the guidewire.One major kink and three bends were observed in the guidewire.Microscopic examination confirmed that both the distal and proximal welds were full and spherical.The kink in the guidewire was located 222 mm from the proximal end.The bends in the guidewire were located 160 mm, 244 mm, and 471 mm from the proximal end.The overall length of the guidewire measured 686 mm, which is within the specification of 679 mm - 687 mm per product drawing.The outer diameter of the guidewire measured 0.790 mm which is within the specification of 0.788 mm-0.826 mm per the guidewire product drawing.The guidewire was functionally tested per the product instructions for use (ifu).The ifu provided with this kit instructs the user, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the undamaged portion of the returned guidewire was advanced through a lab inventory arrow raulerson syringe (ars) with and without a lab inventory 18 ga introducer needle attached.The undamaged portions of the guidewire passed without resistance.A manual tug test confirmed that 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 this kit informs the user, "warning: do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire," and "warning: do not apply undue force on guidewire to reduce risk of possible breakage." the customer report of a kinked guidewire was confirmed through investigation of the returned sample.The guidewire contained one kink and three bends along the body.The guidewire passed all relevant dimensional and functional requirements.A device history record review was performed with no relevant findings.Based on the customer report and the sample received, unintentional user error likely 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 "a cvc was to be placed.After the nurse prepared the necessary materials, the physician performed the cvc insertion under full sterile conditions and protective equipment.The insertion procedure went smoothly.However, when inserting the guidewire, difficulty was encountered.Upon removal, the guidewire was found to be deformed." another guidewire was used.There was no patient harm or injury.The patient's current condition is reported as "fine".

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 30 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: 22965169
• Report Number: 3006425876-2025-00806
• Device Sequence Number: 9142216
• Product Code: FOZ
• UDI-Device Identifier: 00801902102287
• UDI-Public: (01)00801902102287(11)240416(17)260312(10)71F24D0253(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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2025

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: 03/12/2026
• Device Catalogue Number: CS-24703-E
• Device Lot Number: 71F24D0253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Supplement Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2024
• 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