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 and 9680794-2025-00042.
Additional Manufacturer Narrative
Qn#(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 no relevant findings were identified.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 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 and 9680794-2025-00042.

• 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: 21195451
• Report Number: 9680794-2025-00040
• Device Sequence Number: 20904224
• 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?: No
• 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: 02/25/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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