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	02/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the swg kinked prior to the patient insertion.Another kit was opened to start the insertion.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for analysis.The photo shows an opened arterial catheterization kit with a kinked guidewire partly in its tubing.The customer returned the guidewire, protective tubing, and lid stock for evaluation.Visual analysis revealed that the guidewire was kinked in two locations.No obvious signs of use were observed.The damage observed is consistent with defects related to storage and shipping.Microscopic examination confirmed the damage and confirmed the distal and proximal welds were secure and intact.The kinks on the guidewire measured 406mm and 411mm from the proximal tip.The guidewire length measured 457mm, which is within the specification limits of 449.2mm - 458.8mm per guidewire product drawing.The guidewire outer diameter measured 0.62mm, which is within the specification limits of 0.610mm - 0.635mm per the guidewire product drawing.The guidewire was functionally tested per the product instructions for use (ifu).The ifu provided with this kit instructs the user, "insert tip of guidewire through introducer needle into artery (until depth-marking [if provided] on wire enters hub of needle)." the guidewire was advanced through a lab inventory introducer needle, and the undamaged portions were able to pass with little to no resistance.A manual tug test confirmed that the distal and proximal welds were secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit warns the user , "do not use if package is damaged." the customer report of a kinked guidewire was confirmed through complaint investigation of the returned sample.Kinking was observed on the guidewire body in two locations.However, the guidewire met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.Based on the customer description and the samples received, storage and shipping caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that the swg kinked prior to the patient insertion.Another kit was opened to start the insertion.

• 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: 21558453
• Report Number: 9680794-2025-00221
• Device Sequence Number: 4430867
• Product Code: DQX
• UDI-Device Identifier: 50801902117644
• UDI-Public: (01)50801902117644(11)240903(17)261031(10)33F24D0028(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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2025

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: 33F24D0028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2024
• 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