MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH SET:18 GA CATH/20 GA NDL; WIRE GUIDE CATHETER

Catalog Number	FA-04018
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "copious oozing noted from a-line site during dressing change.Assessment revealed the a-line catheter was damaged and needed to be replaced.A small piece of the catheter was broken." 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).
Additional Manufacturer Narrative
(b)(4).The customer returned one s-l catheter and connecting tubing with a stopcock for evaluation.Signs of use in the form of dried biomaterial were observed on the returned device.Visual inspection revealed sutures wrapped around the proximal end of the catheter, around the luer hub.Microscopic examination revealed a hole towards the proximal end of the catheter body.The hole in the catheter was located 1mm from the proximal end.The catheter outer diameter measured 0.0561", which is within the specifications of 0.055" - 0.057" per catheter extrusion product drawing.The inner diameter of the catheter measured 0.038", which is within the specification limits of 0.038" - 0.040" per catheter.Extrusion product drawing.The connecting tubing was removed from the catheter before functionally testing.The returned sample was tested per the ifu statement, "hold catheter in place and remove guidewire and or assembly, where applicable.Pulsatile blood flow indicates positive arterial placement." a lab inventory guidewire was able to pass through with no resistance.The catheter was then flushed with water from a syringe, and a confirmed leak was observed from the proximal end of the extrusion.The defect in the catheter appears consistent with unintentional use error.Misplacement or mispositioning of the catheter may lead to kinking, and repeated stress to the catheter may fatigue the catheter walls and cause tearing.Alternatively, contact with a sharp instrument (i.E.Scissors, scalpel, etc.) could have caused the observed damage.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: do not apply tape, staples, or sutures directly to the catheter body to reduce risk of damaging catheter, impeding catheter flow, or adversely affecting monitoring capabilities.Secure only at indicated stabilization locations." the customer report of a liquid oozing from the catheter was confirmed through complaint investigation of the returned sample.Visual inspection revealed the returned catheter had a slit adjacent to the hub which leaked when functional testing was performed.Additionally, the catheter was returned with sutures wrapped around the proximal end.The catheter met all relevant dimensional requirements, and a device history record review was performed with no relevant findings.Based on the returned sample and the available information, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported "copious oozing noted from a-line site during dressing change.Assessment revealed the a-line catheter was damaged and needed to be replaced.A small piece of the catheter was broken." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW ARTERIAL CATH SET:18 GA CATH/20 GA NDL
• 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: 22413931
• Report Number: 9680794-2025-00564
• Device Sequence Number: 13184773
• Product Code: DQX
• UDI-Device Identifier: 00801902100597
• UDI-Public: (01)00801902100597(11)240202(17)290131(10)13F24A0010(21)
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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
• Device Catalogue Number: FA-04018
• Device Lot Number: 13F24A0010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2024
• 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