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 Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 'when checking the appearance of the product before use, the guide wire at the tip of the device was found to be bent.As a result, the product was not used in the procedure.A new set was opened for the procedure'.
Additional Manufacturer Narrative
Qn# (b) (4).
Event or Problem Description
It was reported that 'when checking the appearance of the product before use, the guide wire at the tip of the device was found to be bent.As a result, the product was not used in the procedure.A new set was opened for the procedure'.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one, opened arterial catheterization kit for analysis.No definite signs of use were observed.Visual analysis revealed three kinks on the guide wire.Two smaller kinks were located adjacent to the distal weld.A larger kink was located just proximal to the tubing adapter component.Microscopic examination revealed white particulate on the distal tip of the guide wire.The distal weld was present and appeared full and spherical.A bubble within the supplied guide wire hub component was additionally noted.The bubbling and the particulate likely contributed to the resistance encountered by the customer, which led to the kinking.Functional testing was performed based on the instructions-for-use (ifu).The ifu provided with this kit states, "stabilize position of introducer needle and carefully advance guidewire into vessel using guidewire handle".An attempt to insert the guide wire was performed; however, resistance was encountered at the proximal opening of the needle cannula.The severity of the kinking prevented the guide wire from passing.This test was repeated with a lab inventory guide wire.No resistance was encountered as the guide wire was able to pass.A device history record review was performed, and no relevant findings were identified.The reported event was confirmed through complaint investigation of the returned sample.Visual and functional analysis revealed particulate on the catheterization device as well as a 'bubble' on the supplied guide wire hub component.These defects created resistance between the guide wire and the cannula.A capa was previously implemented to address this issue.The capa investigation determined that the root cause is manufacturing related.The relevant lots within the reported kit were manufactured (july 2023-march 2024) prior to the implementation of the corrective action (october 2024).Teleflex will continue to monitor and trend for 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: 20961606
• Report Number: 9680794-2024-01248
• Device Sequence Number: 18053944
• Product Code: DQX
• UDI-Device Identifier: 00801902002754
• UDI-Public: (01)00801902002754(11)240524(17)290430(10)14F24E0128(21)
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 11/26/2024

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 Catalogue Number: RA-04122
• Device Lot Number: 14F24E0128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2024
• 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
• Patient Sex: Unknown