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

Catalog Number	AK-04510-S
Medical Device Problem Codes	Material Separation (1562); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Was reported that: inserter placed wire through needle and was then unable to remove wire because it unravelled in the arterial vessel.Additional information: they were able to open the insertion site with a scalpel and remove the wire without doing a cutdown.Another line was placed without incident.There was no reported patient harm or consequence.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one unraveled j-tip guide wire for analysis.Signs of use were observed.The introducer needle was not returned.Visual inspection revealed that the guide wire was separated at the distal end, adjacent to the j-tip.Multiple kinks were observed near the proximal and distal core wire point of separation.Microscopic examination confirmed the damage.Offset coils were observed throughout the curve of the j-tip.Both welds were full and spherical.The broken core wire measured 354mm in total which is within the specifications of 350.0mm - 355.6mm per product drawing.This indicates that all of the core wire was returned and did not remain in the patient.The guide wire outer diameter measured 0.615mm which is within the specifications of 0.610mm-0.635mm per product drawing.Functional inspection of the returned device was performed per the instructions for use (ifu) provided with the kit which states, "insert tip of guidewire through introducer needle into artery (until depth marking [if provided] on wire enters hub of needle)." the undamaged portion of the returned guide wire was threaded through a lab inventory 20 ga introducer needle with no resistance.A manual tug test was performed on the proximal and distal welds.Both welds were revealed to be secure.A device history record review was performed with no relevant findings.The 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." the customer report of a separated arterial guide wire was confirmed through complaint investigation of the returned sample.Visual inspection revealed the core wire separated at the distal end adjacent to the j-tip.The complaint of needle resistance could not be confirmed as the needle was not returned for investigation.The guide wire met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings to suggest a manufacturing-related cause.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Based on these circumstances, and without the complete sample returned for analysis, the probable root cause could not be determined.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported that: inserter placed wire through needle and was then unable to remove wire because it unravelled in the arterial vessel.Additional information: they were able to open the insertion site with a scalpel and remove the wire without doing a cutdown.Another line was placed without incident.There was no reported patient harm or consequence.
Additional Manufacturer Narrative
(b)(4).In section d provided the full udi # **udi related data quality updates only**.
Event or Problem Description
It was reported that: inserter placed wire through needle and was then unable to remove wire because it unravelled in the arterial vessel.Additional information: they were able to open the insertion site with a scalpel and remove the wire without doing a cutdown.Another line was placed without incident.There was no reported patient harm or consequence.

• 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18147156
• Report Number: 9680794-2023-00933
• Device Sequence Number: 7540959
• Product Code: DQX
• UDI-Device Identifier: 20801902121688
• UDI-Public: (01)20801902121688(11)230812(17)250930(10)33F23H0247(21)
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K810675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/19/2023

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: 09/30/2025
• Device Catalogue Number: AK-04510-S
• Device Lot Number: 33F23H0247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 12/05/2023; Not provided
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 12/06/2023; 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2023
• 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; NOT REPORTED
• Patient Sex: Unknown