MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW RA CATH SET: 20 GA X 1-3/4IN; WIRE GUIDE CATHETER

Catalog Number	RA-04020
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "ra inserted and then removed as the steel cannula part of the art line has detached.It had fallen off while still partially within the plastic intra- arterial cannula.Luckily enough was left that they were able to grab and remove." 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 provided two photos for analysis.The photos show the catheterization device with the separated needle and the product lidstock.Definite signs of use were observed.The customer also returned one catheterization device and the product lidstock for analysis.Visual inspection revealed signs of use, including the presence of biological material within the needle and chamber.The needle cannula was found to be separated from the hub, and the distal end of the needle exhibited a noticeable bend.No damage was observed to the guidewire.Microscopic examination revealed that no signs of adhesive were found in the hub and on the cannula.The outer diameter of the needle cannula measured 0.0282", which is within specification limits of 0.0280"-0.0285" per needle cannula product drawing.The inner diameter of the needle hub measured 0.098", which is within the specification limits of 0.095" - 0.105" per needle hub product drawing.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit states, "precaution: if resistance is encountered during guidewire advancement do not force feed, withdraw entire unit and attempt new puncture." it also states, "warning: do not use excessive force in removing catheter.If resistance is met on removal, stop and follow institutional policies and procedures for difficult to remove catheters." the customer report of needle cannula separation from the hub was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the needle cannula had separated from the needle hub.The sample was returned in used condition, with biological material present in the needle and chamber.Microscopic analysis revealed that there were no signs of adhesive inside the hub and along the needle cannula.A device history record review was performed, and no relevant findings were identified.Based on the customer report and condition of the returned sample, manufacturing likely caused or contributed to the reported event.A non-conformance was initiated to further investigate this complaint.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "ra inserted and then removed as the steel cannula part of the art line has detached.It had fallen off while still partially within the plastic intra- arterial cannula.Luckily enough was left that they were able to grab and remove." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW RA CATH SET: 20 GA X 1-3/4IN
• 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: 22727612
• Report Number: 9680794-2025-00662
• Device Sequence Number: 8344632
• Product Code: DQX
• UDI-Device Identifier: 00801902002730
• UDI-Public: (01)00801902002730(11)230715(17)280630(10)14F23G0078(21)
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 07/14/2025

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-04020
• Device Lot Number: 14F23G0078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2023
• 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