MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW RA CATH SET: 22 GA X 1-3/8IN; WIRE GUIDE CATHETER

Catalog Number	RA-04122
Medical Device Problem Codes	Difficult to Advance (2920); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that"(b)(6) 2025, the arterial puncture needle is used in anesthesiology department, and the swg was found difficult to advance, so the product needs to be replaced." the customer confirmed the advancement difficulty was due to kinking of the device.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 (b)(6) 2025, the arterial puncture needle is used in anesthesiology department, and the swg was found difficult to advance, so the product needs to be replaced." the customer confirmed the advancement difficulty was due to kinking of the device.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 assembled arterial catheterization kit for analysis.No signs of use in the form of biological material were observed within the catheterization device.Visual analysis revealed a bend in the needle cannula and two bends in the guidewire tubing.Microscopic analysis revealed offset coils directly adjacent to the distal weld.The distal weld was spherical and intact.The bend in the needle and location of the offset coils are consistent with damage due to excessive force.The offset coils spanned 1 mm from the distal weld.The bend in the needle cannula was located 17 mm from the needle hub.The bends in the guidewire tube were located 35 mm and 75 mm from the guide tube hub.The outer diameter of the guidewire measured 0.398 mm, which is within the specification limits of 0.381 mm - 0.404 mm per guidewire product drawing.The inner diameter of the needle cannula measured 0.0170", which is within the specification limits of 0.0165" -0.0180" per cannula product drawing.Performed per ifu statement, "trial advance and retract guidewire through needle using guidewire handle to ensure proper function.Where provided, catheter hub wing clip may be removed if desired." the guidewire was advanced through the introducer needle.Moderate resistance was felt as the misaligned coils advanced through the needle cannula.Once the misaligned coils exited the cannula, the remaining portion of the guidewire passed with no resistance.A device history record review was performed and no relevant findings were identified.The instructions for use (ifu) provided with the kit warns the user, "warning: to reduce the risk of guidewire damage, do not retract guidewire against edge of needle while in vessel." the customer report of guidewire/needle resistance was confirmed through complaint investigation of the returned sample.Bending was observed on the needle cannula and microscopic examination confirmed offset coils adjacent to the distal weld.Based on the appearance of the damage, unintentional use error likely caused or contributed to the reported event.Teleflex will continue to monitor and trend on reports of this nature.

• Brand Name: ARROW RA CATH SET: 22 GA X 1-3/8IN
• Common Device Name: WIRE GUIDE CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23778215
• Report Number: 9680794-2025-01059
• Device Sequence Number: 10117433
• Product Code: DQX
• UDI-Device Identifier: 00801902002754
• UDI-Public: (01)00801902002754(11)221206(17)271130(10)14F22L0155(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K810675
• 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): 12/10/2025

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: RA-04122
• Device Lot Number: 14F22L0155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2022
• 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