MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATHETER KIT: 18 GA X 16 CM; WIRE, GUIDE, CATHETER

Catalog Number	ASK-04018-UPM
Medical Device Problem Codes	Difficult to Remove (1528); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that during the left femoral arterial line placement, difficulty was encountered to pull the wire back through the needle.The wire and needle were removed together, and wire sheared at the tip.The fractured wire was retrieved by interventional radiology.The patient was fine and had no harm or injury.
Additional Manufacturer Narrative
Qn#(b)(4).The actual device was not returned; however, the customer provided two photos for analysis.The complaint of guide wire separation cannot be confirmed by the photos.The first photo revealed the guide wire assembly and other kit contents, however there was not clear visual evidence of guide wire separation.The second photo revealed the lidstock information.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "warning: to reduce the risk of guidewire damage, do not retract guidewire against edge of needle while in vessel." without the device to evaluate, 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 during the left femoral arterial line placement, difficulty was encountered to pull the wire back through the needle.The wire and needle were removed together, and wire sheared at the tip.The fractured wire was retrieved by interventional radiology.The patient was fine and had no harm or injury.

• Brand Name: ARROW ARTERIAL CATHETER KIT: 18 GA X 16 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: 21124836
• Report Number: 9680794-2025-00048
• Device Sequence Number: 15623798
• Product Code: DQX
• UDI-Device Identifier: 50801902117644
• UDI-Public: (01)50801902117644(11)231029(17)260228(10)33F23K0747(21)
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2024

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: 02/28/2026
• Device Catalogue Number: ASK-04018-UPM
• Device Lot Number: 33F23K0747
• 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: 12/17/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2023
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Unknown