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".
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".
Additional Manufacturer Narrative
(b)(4).The customer returned one opened cvc kit including a guidewire, arrow raulerson syringe (ars), dilator, transduction probe, catheter-over-needle, and two introducer needles.Signs of use in the form of biological material were observed on the returned components.Visual analysis revealed a bend in the guidewire body.Microscopic examination confirmed the distal and proximal welds were spherical and intact.The bend in the guidewire was located 180 mm from the proximal end.The overall guidewire length measured 456 mm, which is within the specification limits of 450 mm - 458 mm per the guidewire product drawing.The guidewire outer diameter measured 0.790 mm, which is within the specification limits of 0.788 mm - 0.826 mm per the guidewire product drawing.The guidewire was functionally tested per the product instructions for use (ifu) which instructs the user to "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the guidewire was advanced through the returned ars with and without the returned 18 ga introducer needles attached.The guidewire passed with no 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 warns 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 customer report of a damaged guidewire was confirmed through investigation of the returned sample.One bend was observed on the guidewire 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 damage observed on the sample, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• 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: 24442821
• Report Number: 3006425876-2026-00214
• Device Sequence Number: 13374031
• 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

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: 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: 01/29/2202
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 02/25/2026
• 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