MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL LINE KIT; WIRE GUIDE CATHETER

Catalog Number	AK-04510-S
Medical Device Problem Codes	Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer returned one guide wire advanced through a 20ga introducer needle for analysis.Signs of use in the form of biological material were observed on the returned components.Visual and microscopic revealed the guide wire was advanced past the needle bevel and had one kink adjacent to the bevel and two on the j-bend.The distal and proximal welds were full and spherical.The guide wire was removed from the introducer needle during functional analysis and dried biological material was observed on the portion of the guide wire that was within the needle cannula.The kinks in the guide wire measured 8 mm, 9 mm, and 19 mm from the distal tip.The overall length of the guide wire measured 352 mm, which is within the specification limits of 350.0-355.6 mm per guide wire product drawing.The outer diameter of the guide wire measured 0.611 mm, which is within the specification limits of 0.610-0.635 mm per guide wire product drawing.The inner diameter of the needle cannula measured 0.027", which is within the specification limits of 0.0270"-0.0285" per needle cannula product drawing.Functional testing was performed based on the instructions-for-use (ifu).The ifu provided with this kit states, "insert tip of guidewire through introducer needle into artery (until depth marking [if provided] on wire enters hub of needle)." the guide wire attempted to be retracted to re-advance through the returned cannula; however, the guide wire was stuck within the cannula due to biological material.The guide wire was removed and was able to advance through the needle cannula with little to no resistance.The condition of the sample suggests the guide wire was advanced through the needle cannula and encountered resistance resulting in the guide wire to kink.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit warns the user, "precaution: 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 report of guide wire and needle resistance with a kinked guide wire was confirmed through complaint investigation of the returned sample.Visual and functional analysis revealed the guide wire was kinked towards the distal end and dried biological material was within the needle.The condition of the sample and the customer report suggests the guide wire was advanced through the needle cannula and encountered resistance when removing the guide wire resulting in the guide wire to kink.Based on these circumstances , unintentional use error likely contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "arterial line guidewire malfunction.Guidewire stripped of metal within needle caused a kink in wire, unable to remove wire from needle caused failed arterial line insertion.There was no harm to the patient only minor monitoring.".

• Brand Name: ARROW ARTERIAL LINE KIT
• 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20864979
• Report Number: 9680794-2024-01206
• Device Sequence Number: 8694020
• Product Code: DQX
• UDI-Device Identifier: 20801902121688
• UDI-Public: (01)20801902121688(11)240729(17)261231(10)33F24E0047(21)
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K810675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/14/2024

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: AK-04510-S
• Device Lot Number: 33F24E0047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2024
• 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.
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 59 KG