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 Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the wire was unable to be withdrawn from the catheter and was curling.The wire was removed in its entirety and a new catheter was placed in the same site.The patient had no harm or injury.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the wire was unable to be withdrawn from the catheter and was curling.The wire was removed in its entirety and a new catheter was placed in the same site.The patient had no harm or injury.
Additional Manufacturer Narrative
(b)(4).The customer provided two images for analysis.The photos show the guide wire inserted through the catheter body.Large quantities of biological material were observed on the catheter body.Visual analysis also revealed kinking towards the distal end of the guide wire.The customer also returned one arterial catheter, guide wire, and lidstock for analysis.The guide wire was observed lodged inside the catheter body.Large quantities of biological material were observed on the guide wire and the catheter.Visual analysis revealed that the distal end of the guide wire was kinked.Undue force was required to dislodge the guide wire from the catheter body.Once removed, large quantities of dried biological material were observed exiting the catheter body.This biological material in combination with the kinking likely contributed to this event.The major kinks on the guide wire measured 425mm, 436mm, 439mm from the proximal weld.The guide wire total length measured 17 15/16", which is within the specification limits of 17 11/16"-18 1/16" per the guide wire product drawing.The guide wire outer diameter measured 0.024", which is within the specification limits of 0.024"-0.025" per the guide wire product drawing.The catheter body length measured 6", which is within the specification limits of 5 13/16"-6 3/16" per the catheter product drawing.The catheter inner diameter at the distal tip measured 0.034", which is within the specification limits of 0.033"-0.035" per the catheter product drawing.The catheter outer diameter measured 0.056", which is within the specification limits of 0.055"-0.059" per the catheter extrusion product drawing.The catheter inner diameter at the proximal end measured 0.037", which is within the specification limits of 0.037"-0.039" per the catheter extrusion product drawing.An attempt to remove the guide wire from the catheter was performed; however, resistance was encountered.Moderate force was applied and the guide wire dislodged from the cannula.Large quantities of dried biological material were observed exiting the catheter body.The biological material was removed, and the proximal end of the guide wire was reinserted through the catheter tip.All functional portions of the guide wire were able to pass with no resistance.Performed per ifu statement, "thread tip of catheter over spring-wire guide".A manual tug test confirmed that the distal and proximal welds were secure and intact.A device history record review did not reveal any relevant findings.The ifu provided with the kit informs the user, "use care when removing spring-wire guide.If resistance is encountered, remove spring-wire guide and catheter together as a unit.Use of excessive force may damage catheter or spring-wire guide".The report of guide wire/catheter resistance was confirmed through complaint investigation of the returned sample.Visual analysis revealed three major kinks towards the distal end of the guide wire.This in combination with dried biological material created the resistance encountered by the customer.Despite the damage, the catheter and guide wire met all relevant dimensional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received , unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• 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: 21663270
• Report Number: 9680794-2025-00245
• Device Sequence Number: 18067485
• Product Code: DQX
• UDI-Device Identifier: 50801902117644
• UDI-Public: (01)50801902117644(11)230227(17)280131(10)33F23B0953(21)
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 03/04/2025

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: ASK-04018-UPM
• Device Lot Number: 33F23B0953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2023
• 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
• Patient Sex: Unknown