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

Catalog Number	AK-04510-S
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "it has come to my attention that this lot is faulty.The physician attempted to use six kits, and all resulted in the issue: the guidewire when pulled out, pulls out the whole catheter.".Additional information from the nurse indicated that multiple attempts were made on various arterial lines, including axillary, femoral, and radial, but the guidewire could not be threaded.Initially, it was thought that this issue was due to the patient having peripheral artery disease (pad); however, the problem has occurred with numerous patients.In cases where the guidewire was successfully threaded, it could not be removed, as it became stuck in the patient.Additionally, the guidewire would get stuck in the artery along with the needle, and upon removal, it was consistently found to be bent.There have been no reported medical conditions or interventions resulting from the use of these kits.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed, and a relevant finding was identified.A non-conformance was initiated for batch 14p24c0187 to address the issue of a visual defect on the catheter extrusion.Despite this finding, it cannot be determined if this failure is the same defect involved with this complaint without the sample returned for analysis.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "it has come to my attention that this lot is faulty.The physician attempted to use six kits, and all resulted in the issue: the guidewire when pulled out, pulls out the whole catheter.".Additional information from the nurse indicated that multiple attempts were made on various arterial lines, including axillary, femoral, and radial, but the guidewire could not be threaded.Initially, it was thought that this issue was due to the patient having peripheral artery disease (pad); however, the problem has occurred with numerous patients.In cases where the guidewire was successfully threaded, it could not be removed, as it became stuck in the patient.Additionally, the guidewire would get stuck in the artery along with the needle, and upon removal, it was consistently found to be bent.There have been no reported medical conditions or interventions resulting from the use of these kits.The associated emdr report numbers are 9680794-2025-00153, 9680794-2025-00158, 9680794-2025-00164, 9680794-2025-00163, 9680794-2025-00162, 9680794-2025-00161, 9680794-2025-00160, 9680794-2025-00159 and 9680794-2025-00157.

• 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: 21409706
• Report Number: 9680794-2025-00162
• Device Sequence Number: 15789128
• Product Code: DQX
• UDI-Device Identifier: 20801902121688
• UDI-Public: (01)20801902121688(11)241126(17)270331(10)33F24J0676(21)
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 02/07/2025

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: 33F24J0676
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2024
• 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: Unknown