MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL LINE KIT; CATHETER, PERCUTANEOUS

Catalog Number	ASK-04510-UPM
Medical Device Problem Codes	Difficult to Remove (1528); Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "patients radial atrial line was accidentally removed while on 3 vasopressors.Attempted to reestablish radial arterial access with no success.When attempt was made to place femoral arterial line, i was able to easily cannulate the artery with my needle, had great pulsatile blood flow, but when i attempt to thread the guide wire, i was unable to advance and had difficulty removing the wire.When i was finally able to remove the wire, it was kinked".There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "patients radial atrial line was accidentally removed while on 3 vasopressors.Attempted to reestablish radial arterial access with no success.When attempt was made to place femoral arterial line, i was able to easily cannulate the artery with my needle, had great pulsatile blood flow, but when i attempt to thread the guide wire, i was unable to advance and had difficulty removing the wire.When i was finally able to remove the wire, it was kinked".There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).The actual device was not returned; however, the customer provided three photos for analysis.The complaint of a kinked guide wire was able to be confirmed by the photos as they revealed the guide wire advanced within the needle and kinked in multiple locations towards exposed the distal end.Evidence of use in the form of biological material was also observed.However, without the sample returned for analysis, a complete visual inspection could not be performed.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit informs the user, "precaution: do not advance guidewire unless there is free blood flashback.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.

• Brand Name: ARROW ARTERIAL LINE KIT
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 20255567
• Report Number: 9680794-2024-00908
• Device Sequence Number: 7886399
• Product Code: DQY
• UDI-Device Identifier: 10801902118087
• UDI-Public: (01)10801902118087(11)231030(17)250930(10)33F23K0755(21)
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K810962
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2024

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
• Device Expiration Date: 09/30/2025
• Device Catalogue Number: ASK-04510-UPM
• Device Lot Number: 33F23K0755
• 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: 08/27/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2023
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown