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 Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported "one of set luer-hub broken.One of set guide wire broken." additional information received from the customer states the guide wire was " separated in two pieces".The device was removed and replaced.There was no patient harm or injury.The patient's current condition is reported as "fine".Associated mdr numbers include:3006425876-2025-00376 and 3006425876-2025-00375.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one guide wire assembly for analysis.The needle involved with this complaint was not returned.Signs of use in the form of biological material were observed on the guide wire surface.Visual analysis revealed that the guide wire was unraveled from the distal end.Severe kinking and bending were also noted across the entire guide wire.Microscopic examination confirmed the damage and revealed that the distal weld was completely separated from the core and coil wires.The separated weld was not returned.Further analysis revealed that the proximal weld was full and spherical.The major kink on the guide wire measured 275mm from the proximal weld.The guide wire length from the proximal weld to the point of separation on the core wire measured 600mm, which is within the specification limits of 596mm-604mm per the guide wire product drawing.The outer diameter measured 0.840mm, which is within the specification limits of 0.838mm-0.877mm per the guide wire product drawing.A manual tug test confirmed that the proximal weld was 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 report of a separated guide wire was confirmed through analysis of the returned sample.Visual analysis revealed that the distal weld was separated from both the core wire and coil wire.The guide wire met all relevant dimensional requirements, and a device history record review was performed with no relevant findings.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.This internal specification is higher than the bs en iso 11070 standard of 2.2 pounds force for this size wire.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Based on the returned sample, the damage seems consistent with an unintentional use error due to undue force applied during insertion/removal; however, without the separated portion of the guide wire and the introducer needle also returned, the root cause cannot be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "one of set luer-hub broken.One of set guide wire broken." additional information received from the customer states the guide wire was " separated in two pieces".The device was removed and replaced.There was no patient harm or injury.The patient's current condition is reported as "fine".Associated mdr numbers include:3006425876-2025-00376 and 3006425876-2025-00375.

• 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: 21847165
• Report Number: 3006425876-2025-00376
• Device Sequence Number: 7852093
• Product Code: FOZ
• UDI-Device Identifier: 00801902102188
• UDI-Public: (01)00801902102188(11)240213(17)260103(10)71F24B0784(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,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

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: 01/03/2026
• Device Catalogue Number: CS-22123-F
• Device Lot Number: 71F24B0784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 04/16/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2024
• 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