MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH KIT: 20 GA X 5 IN; WIRE, GUIDE, CATHETER

Catalog Number	ASK-04510-HFH4
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	06/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "catheters wont thread on insertion.They are buckling." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers include: 9680794-2025-00573.
Additional Manufacturer Narrative
(b)(4) the customer returned one s-l catheter and the lidstock for the finished good for evaluation.Signs of use in the form of dried biomaterial were observed on the returned device.Visual inspection revealed the bending of the catheter body towards the distal end and damage to the distal tip.Microscopic examination confirmed the damage to the distal tip, which appeared to be misshapen.The bending in the catheter body started from approximately 56mm and continued throughout the distal portion of the extrusion.The catheter outer diameter measured 0.0449", which is within the specification limits of 0.044" - 0.046" per the catheter product drawing.The catheter inner diameter measured 0.027", which is within the specification limits of 0.027" - 0.029" per the catheter product drawing.The catheter inner diameter at the distal tip could not be accurately measured due to the damage.A lab inventory 0.533mm guidewire was inserted through the returned catheter.Minor resistance was encountered at the location of the bend; however, the guidewire was able to pass.Performed per ifu statement, "thread tip of catheter over guidewire." a device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "use care when removing guidewire.If resistance is encountered, remove guidewire and catheter together as a unit.Use of excessive force may damage catheter or guidewire." the ifu also states, "care should be exercised that the catheter is not inadvertently kinked at the hub area when securing catheter to the patient as this may result in catheter damage, breakage and loss of arterial monitoring capabilities." the customer report of a kinked catheter was confirmed through complaint investigation of the returned sample.Visual inspection revealed that the catheter extrusion contained a continuous bend along the distal end.Additionally, the distal tip was damaged and misshapen.The appearance of the damage is consistent with inadvertent undue force applied during insertion.The catheter met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.Based on the report, the damage was identified during use and the appearance of the returned sample, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported "catheters wont thread on insertion.They are buckling." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers include: 9680794-2025-00573 and 9680794-2025-00574.

• Brand Name: ARROW ARTERIAL CATH KIT: 20 GA X 5 IN
• 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: 22437267
• Report Number: 9680794-2025-00574
• Device Sequence Number: 3152575
• Product Code: DQX
• UDI-Device Identifier: 10801902200454
• UDI-Public: (01)10801902200454(11)241203(17)260820(10)33F24J0167(21)
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K810675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• 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 Expiration Date: 08/20/2026
• Device Catalogue Number: ASK-04510-HFH4
• Device Lot Number: 33F24J0167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2025
• 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: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2024
• 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