MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number	CV-17702-E
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "(b)(6) 2025, when teacher (b)(6) from the emergency department of (b)(6) hospital was performing catheterization, the guidewire was found kinked.A new catheter was replaced promptly." 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 guide wire.Signs of use were observed on the guide wire and in the introducer cap.No kinks observed on the guide wire body.The distal j-bend was misshapen.Microscopic examination confirmed that both welds were present and appeared to be full and spherical.The overall length of the guide wire measured 602mm, which is within the specification limits of 596-604mm per guide wire product drawing.The outer diameter of the guide wire measured 0.792mm, which is within the specification limits of 0.788-0.826-mm per guide wire product drawing.The guide wire was functionally tested in accordance with the product instructions for use (ifu).The ifu provided with this kit instructs the user to "advance the guide wire into the arrow raulerson syringe approximately 10 cm until it passes through the syringe valves or into the introducer needle." functional testing was performed by advancing the guide wire through a laboratory inventory arrow raulerson syringe (ars) and a laboratory inventory 18-gauge introducer needle.Minimal resistance was observed at the misshapen j-bend area, while the undamaged portions of the guide wire advanced through the ars and introducer needle without resistance.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed, and no relevant findings were identified.The instructions caution , "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." examination of the returned guide wire confirmed that the distal j-bend was misshapen.No kinks were observed.The guide wire met all applicable dimensional requirements.Functional testing demonstrated minimal resistance at the misshapen j-bend area, while the undamaged portions of the guide wire advanced through the arrow raulerson syringe (ars) and introducer needle without resistance.A review of the device history record (dhr) did not identify any manufacturing-related nonconformances.Based on the condition of the returned device and information indicating the damage was observed during use, the findings are consistent with unintentional use error.Teleflex will continue to monitor and trend complaints of this nature.
Event or Problem Description
It was reported that "(b)(6) 2025, when teacher zuo from the emergency department of china-japan friendship hospital was performing catheterization, the guidewire was found kinked.A new catheter was replaced promptly." 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: 2-LUMEN 7 FR X 20 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: 24052879
• Report Number: 3006425876-2026-00026
• Device Sequence Number: 9421018
• Product Code: DQY
• UDI-Device Identifier: 10801902183771
• UDI-Public: (01)10801902183771(11)240208(17)290131(10)71F24A1733(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): 12/16/2025

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 Catalogue Number: CV-17702-E
• Device Lot Number: 71F24A1733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2024
• 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