MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 12 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CS-25123-F
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "when the guidewire is pulled out, the outer full steel wire separates from the central steel wire, which may cause vascular injury." the user changed to a new set.There was no patient complications.The patient's current condition is reported as "unknown".Associated mdr numbers include: 3006425876-2025-00802, 3006425876-2025-00801, and 3006425876-2025-00800.
Event or Problem Description
It was reported "when the guidewire is pulled out, the outer full steel wire separates from the central steel wire, which may cause vascular injury." the user changed to a new set.There was no patient complications.The patient's current condition is reported as "unknown".Associated mdr numbers include: 3006425876-2025-00774, 3006425876-2025-00802, 3006425876-2025-00801, and 3006425876-2025-00800.
Additional Manufacturer Narrative
(b)(4) the customer returned one guidewire for analysis.Visual inspection revealed numerous kinks throughout the guide wire and the core wire was unraveled at the proximal end.Microscopic examination revealed that the core wire had broken adjacent to the proximal weld.The kinks in the guidewire body measured from 318mm-678mm from the from the distal end.The overall length of the broken core wire measured 678mm, which is within the specification limits of 678mm - 688mm per the guidewire product drawing; therefore, no pieces of the core wire were missing.The outer diameter of the guidewire measured 0.850mm, which is within the specification limits of 0.838mm - 0.877mm per the guidewire product drawing.Functional testing was not able to be performed due to the nature of the damage.A manual tug test confirmed that the distal weld was intact.A device history record review was performed, and no relevant manufacturing issues were identified.The instructions for use (ifu) provided with this product warns the user, "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." it also states "warning: do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire." the report that the guidewire unraveled during use was confirmed through examination of the returned sample.The core wire was broken adjacent to the proximal weld.The guidewire met all relevant dimensional requirements during investigation testing.No manufacturing defects were found during this investigation.Arrow guidewires of this size are designed and manufactured to withstand a tensile force of 2.0 pounds force.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guidewire breakage may occur if a force greater than the design specification is applied during removal.Based on these circumstances, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend reports of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 12 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: 22902408
• Report Number: 3006425876-2025-00774
• Device Sequence Number: 9089139
• Product Code: FOZ
• UDI-Device Identifier: 00801902102300
• UDI-Public: (01)00801902102300(11)240506(17)260321(10)71F24D1541(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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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
• Device Expiration Date: 03/21/2026
• Device Catalogue Number: CS-25123-F
• Device Lot Number: 71F24D1541
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2024
• 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