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	10/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: provider was placing an artline the guidewire met resistance while advancing, when slowly retracting the guidewire, the core snapped, and the wire began to unravel with approx 1.5 inches of guidewire inside the body beyond the insertion site.A hemostat was used to remove the section of guidewire from the patient successfully intact.Xray was performed to confirm no foreign body in patient.Patient is reported as fine post the procedure.
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that: provider was placing an artline the guidewire met resistance while advancing, when slowly retracting the guidewire, the core snapped, and the wire began to unravel with approx 1.5 inches of guidewire inside the body beyond the insertion site.A hemostat was used to remove the section of guidewire from the patient successfully intact.Xray was performed to confirm no foreign body in patient.Patient is reported as fine post the procedure.
Additional Manufacturer Narrative
(b)(4) the actual device was not returned; however, the customer provided one photo for analysis.The complaint of a damaged guide wire was able to be confirmed by the photo.The image shows a guide wire partially advanced through an introducer needle.Evidence of kinking can be observed on the guide wire, however, it cannot be confirmed if unraveling or separation occurred.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." the customer report of a damaged guide wire was confirmed by visual inspection of the customer supplied photo.The image shows a guide wire partially advanced through an introducer needle.Evidence of kinking can be observed on the guide wire, however, it cannot be confirmed if unraveling or separation occurred.Full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.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.
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that: provider was placing an artline the guidewire met resistance while advancing, when slowly retracting the guidewire, the core snapped, and the wire began to unravel with approx 1.5 inches of guidewire inside the body beyond the insertion site.A hemostat was used to remove the section of guidewire from the patient successfully intact.Xray was performed to confirm no foreign body in patient.Patient is reported as fine post the procedure.

• 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: 18226045
• Report Number: 9680794-2023-00921
• Device Sequence Number: 6221687
• 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: NC
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 09/30/2025
• Device Catalogue Number: AK-04510-S
• Device Lot Number: 33F23H0247
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 12/21/2023; Not provided
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 12/27/2023; 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown