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

Catalog Number	AK-04510-S
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the physician experienced an issue with the guidewire while placing a femoral arterial line, which was being used to monitor pressure.A total of four kits were required to successfully complete the line insertion.The guidewires in the first three kits kinked and would not advance to complete the insertion.Additionally, the guidewire in the third kit would neither advance nor retract.The associated emdr report numbers are 9680794-2025-00041, 9680794-2025-00040.
Additional Manufacturer Narrative
(b)(4).The customer returned one guidewire for analysis.Signs of use were observed on the guidewire surface.The 20ga introducer needle came stuck to the guidewire.Visual analysis revealed that the guidewire and needle cannula contained kinks and other bends across the body.Microscopic examination confirmed the damage and revealed that the distal j-bend was misshapen.It was also noted that the distal and proximal welds were full and spherical.The kinks on the guidewire measured 41mm and 197mm from the proximal weld.The guidewire total length measured 351mm, which is within the specification limits of 350mm - 355.6mm per the guidewire product drawing.The guidewire outer diameter measured 0.61mm, which is within the specification limits of 0.610mm - 0.635mm per the guidewire product drawing.The kink on the needle cannula measured 5/16" from the hub.The needle cannula length measured 2 1/8" , which is within the specification limits of 2.080" - 2.150" per the needle product drawing.The outer diameter measured 0.36", which is within the specification limits of 0.0355" - 0.0360" per the needle cannula product drawing.The inner diameter could not be measured due to the guidewire/needle resistance.The guidewire and needle could not be separated due to resistance from the strong accumulation of biomaterial.However, the remaining portion of the guidewire was tested using a lab inventory 20ga introducer needle.The guidewire was inserted through the lab inventory needle and resistance was encountered at the location of the kinks; however, the undamaged portions of the guidewire were able to pass as expected.Performed per ifu statement, "insert tip of spring-wire guide through introducer needle into artery".A manual tug test confirmed that the distal and proximal welds were secure and intact.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 spring-wire guide.If resistance is encountered, remove spring-wire guide and catheter together as a unit.Use of excessive force may damage catheter or spring-wire guide".The report of a kinked guidewire was confirmed through analysis of the returned sample.Kinks and bends were observed on both the guidewire and needle cannula.Despite the damage, the guidewire met all relevant dimensional requirements, and a device history record review did not reveal any relevant findings.Excess biological material was observed within the device resulting in the resistance between the guidewires and cannula.Based on the customer report and sample received, unintentional use error likely caused or contributed to the reported event.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported that the physician experienced an issue with the guidewire while placing a femoral arterial line, which was being used to monitor pressure.A total of four kits were required to successfully complete the line insertion.The guidewires in the first three kits kinked and would not advance to complete the insertion.Additionally, the guidewire in the third kit would neither advance nor retract.The associated emdr report numbers are 9680794-2025-00041, 9680794-2025-00040.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21195456
• Report Number: 9680794-2025-00042
• Device Sequence Number: 20904226
• Product Code: DQX
• UDI-Device Identifier: 20801902121688
• UDI-Public: (01)20801902121688(11)240826(17)290731(10)33F24G0327(21)
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2025

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: AK-04510-S
• Device Lot Number: 33F24G0327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2024
• 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: Female