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	10/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "during the pre-test after assembly, it was found that the guidewire was twisted/kinked.The ifu does not include any instruction to pull the handle back to its original position during the assembly or trial phase of the needle hub and spring-wire tube".No patient involvement.
Additional Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
Qn# (b)(4) the customer returned one, opened and assembled ra-04122 arterial kit for analysis.No obvious signs of use were observed.Visual analysis revealed that the guidewire was not kinked and the tubing had a very minor bend observed.Microscopic examination revealed evidence of material flash was observed in the connector hub component.The guidewire was advanced in the returned assembly and resistance was not encountered as the guidewire passed completely through the cannula.Performed per the ifu provided with this kit, which states, "stabilize position of introducer needle and carefully advance guidewire into vessel using guidewire handle." functional inspection also revealed the catheter hub was not secure on the assembly.A device history record review was performed, and no relevant findings were identified.The report of a kinked guidewire was not confirmed through complaint investigation.Visual analysis revealed that the guidewire was undamaged within the tubing and could be advanced through the needle cannula with minimal resistance.Finished good ra-04122 consists of two components - guide wire tube (a-04122-006a) and catheter/needle (a-04122-012) - which are assembled by the user via insertion of the hub adapter into the needle hub.Evidence of material flash was observed in the connector hub component which could contribute to the resistance reported by the customer.Manufacturing was contacted and stated the potential of mispositioning of the guide wire during assembly and the flash within the adapter will need to be further investigated at the manufacturing facility.Based on these circumstances, manufacturing likely caused or contributed to the reported event.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend on reports of this nature.Other remarks: corrected data:.
Event or Problem Description
It was reported that "during the pre-test after assembly, it was found that the guidewire was twisted/kinked.The ifu does not include any instruction to pull the handle back to its original position during the assembly or trial phase of the needle hub and spring-wire tube".No patient involvement.

• 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: 23597100
• Report Number: 9680794-2025-00964
• Device Sequence Number: 13334956
• Product Code: DQX
• UDI-Device Identifier: 00801902002754
• UDI-Public: (01)00801902002754(11)241001(17)290930(10)14F24J0261(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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: RA-04122
• Device Lot Number: 14F24J0261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2024
• 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: N/A.; N/A.
• Patient Sex: Unknown