MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 14 GA X 6" (16 CM); CATHETER PERCUTANEOUS

Catalog Number	CS-24706-E
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that (b)(6) 2025, (b)(6) hospital, neurosurgery department, the doctor found the swg kinked during use on the patient." 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 opened cvc kit with multiple components for evaluation.Visual analysis of the guidewire revealed four kinks and bending along the body.Definite signs of use were observed.The distal j-bend was not intact, and the coil wire was completely unraveled.The spring coil was still attached at the proximal end.Microscopic analysis of the guidewire confirmed that the distal weld was separated from both the core and coil wire and was not returned.The proximal weld was present; however, it was also separated from the core wire, which allowed the entire core wire to separate from the coil wire.The kinks in the guidewire were measured at 46mm, 100mm, 122mm, 184mm, and 366mm from the proximal end.The overall core wire length measured 398mm , which is not within the specification limits of 450mm - 458mm per the guidewire product drawing.This suggests that approximately 52mm - 60mm of the core wire was separated and not returned.The outside diameter (od) of the guidewire measured 0.79mm , which is within the specification limits of 0.788mm - 0.826mm per the guidewire product drawing.A manual tug test confirmed that both welds were separated from the core wire.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit 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." the customer report of the guidewire being kinked during use was confirmed through examination of the returned sample.The returned guidewire was unraveled and separated from both the proximal and distal welds.Multiple kinks and bends were also found throughout the core wire body.No manufacturing defects were found during this investigation.Arrow guidewires of this size are designed and manufactured to withstand a tensile force of 2.00 pounds force.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guidewire kinking.Guidewire breakage may occur if a force greater than the design specification is applied during removal.Based on the customer report and the sample received, the appearance of the damage seems consistent with undue force being applied during insertion or removal; however, the root cause is undetermined, as a section of the guidewire was separated and not returned for analysis.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "on (b)(6) 2025, (b)(6) hospital, neurosurgery department, the doctor found the swg kinked during use on the patient." 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".

• Brand Name: ARROW CVC SET: 14 GA X 6" (16 CM)
• Common Device Name: CATHETER PERCUTANEOUS
• 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: 24430340
• Report Number: 3006425876-2026-00216
• Device Sequence Number: 10297828
• Product Code: DQY
• UDI-Device Identifier: 10801902102291
• UDI-Public: (01)10801902102291(11)240711(17)260620(10)71F24G0082(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K862056
• 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): 01/29/2026

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 Expiration Date: 06/20/2026
• Device Catalogue Number: CS-24706-E
• Device Lot Number: 71F24G0082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2024
• 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