MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARTERIAL LINE KIT: 1L 20 GA X 12 CM; WIRE, GUIDE, CATHETER

Catalog Number	ASK-04510-HA
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "guidewire would not come out through the catheter.Clinician felt resistance so they pulled out the catheter and guidewire and started the procedure over with a new kit and had to re-stick the patient." there was no reported patient harm or injury.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "guidewire would not come out through the catheter.Clinician felt resistance so they pulled out the catheter and guidewire and started the procedure over with a new kit and had to re-stick the patient." there was no reported patient harm or injury.
Additional Manufacturer Narrative
(b)(4).The customer returned one guide wire and product lidstock for analysis.No definite signs of use were observed on the guide wire.Visual analysis revealed that the guide wire was kinked towards the distal end.The distal j-bend appeared intact.Microscopic examination confirmed the damage and revealed that both welds were full and spherical.Visual analysis of the catheter could not be performed as it was not returned for analysis.The guide wire kink measured 314mm from the proximal end.The guide wire offset coils measured 340mm from the proximal end.The overall length of the guide wire measured 354mm which is within the specification limits of 350-355.6mm per the guide wire product drawing.The outer diameter (od) of the guide wire measured 0.610mm which is within the specification limits of 0.610-0.635mm per the guide wire product drawing.The guide wire was functionally tested per the instructions for use (ifu) provided with this kit, which instructs the user, "thread tip of catheter over guidewire.".The guide wire was advanced through a lab inventory catheter and passed with little to no resistance.Functional analysis of the catheter could not be performed as it was not returned for analysis.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 this kit informs 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 customer report of a kinked guide wire was confirmed through the investigation of the returned sample.However, resistance between the guide wire and catheter could not be confirmed as the catheter was not returned for analysis.Visual analysis revealed that the guide wire was kinked towards the distal end.Despite this, the guide wire passed all relevant dimensional and functional requirements, and a device history record review did not reveal any relevant findings to suggest a manufacturing cause.The appearance of the damage is consistent with unintentional use error, but without the reported catheter returned for analysis, the potential root cause cannot be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARTERIAL LINE KIT: 1L 20 GA X 12 CM
• 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: 19358009
• Report Number: 9680794-2024-00497
• Device Sequence Number: 11708580
• Product Code: DQX
• UDI-Device Identifier: 20801902121466
• UDI-Public: 20801902121466
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K810675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2024

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 Expiration Date: 06/30/2025
• Device Catalogue Number: ASK-04510-HA
• Device Lot Number: 33F23H0922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2024
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 05/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2023
• 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