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	Insufficient Information (4580)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "kink observed on the guide wire during use on the patient." the patient's current condition is reported as "unknown".
Additional Manufacturer Narrative
(b)(4).The customer returned one catheterization device for evaluation.The device was returned with the guide wire partially advanced past the needle bevel.Signs of use in the form of biological material were observed within the needle hub and guide wire tube.Visual inspection revealed the guide wire had a kink towards the distal end, adjacent to the needle bevel.Microscopic inspection of the guide wire confirmed the damage, and the distal weld was observed to be full and spherical.The kink in the guide wire was located 8 mm from the distal tip.The guide wire outer diameter measured 0.385 mm, which is within the specifications of 0.381-0.404 mm per guide wire product drawing.The guide wire was functionally tested per the product instructions for use (ifu).The ifu provided with this kit instructs the user, "trial advance and retract guidewire through needle using guidewire handle to ensure proper function." the guide wire was completely stuck within the needle cannula.Unintentional undue force was used to retract the guide wire and the guide wire unraveled.Functional testing could not be performed due to the biological material within the device.A manual tug test confirmed the distal weld was intact.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "warning: to reduce the risk of guidewire damage, do not retract guidewire against edge of needle while in vessel.Precaution: if resistance is encountered during guidewire advancement do not force feed, withdraw entire unit and attempt new puncture." the customer report of a kinked guide wire was confirmed through complaint investigation of the returned sample.Visual inspection revealed the guide wire had one kink towards the distal end.A device history record review was performed with no relevant findings.Based on these circumstances, it is unknown whether a blockage within the needle cannula prior to use, unintentional undue force, or biological material may have caused or contributed to the reported event.Therefore, the root cause cannot be determined.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported "kink observed on the guide wire during use on the patient." the patient's current condition is reported as "unknown".

• 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: 22438829
• Report Number: 9680794-2025-00578
• Device Sequence Number: 4670088
• Product Code: DQX
• UDI-Device Identifier: 00801902002754
• UDI-Public: (01)00801902002754(11)240923(17)290831(10)14F24J0174(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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2025

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: RA-04122
• Device Lot Number: 14F24J0174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2024
• 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