MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW RAD ART:20GAX3.81CM / ART LINE:20GAX12CM; WIRE, GUIDE, CATHETER

Catalog Number	ASK-04500-HF-S
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "guidewire was kinked when taken out of the tray.Explained that this has happened approximately 5 times over the past year".This was found prior to use.There was no patient involvement.Associated mdr numbers include: 9680794-2025-00862 and 9680794-2025-00863.
Additional Manufacturer Narrative
(b)(4) the customer returned one guidewire and lidstock for analysis.The product packaging was not returned.Signs of use were observed on the guidewire.Visual analysis revealed one kink.Microscopic examination confirmed the damage and revealed that both welds were secure and intact.The kink on the guidewire measured 292mm from one end.The guidewire length measured 338mm, which is within the specification limits of 331mm - 339.8mm per guidewire product drawing.The guidewire outer diameter measured 0.61mm, 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 20-ga introducer needle, and the undamaged portions were able to pass with little to no resistance.A manual tug test confirmed that both welds were intact.A device history record review was performed, and no relevant findings were identified.The current ifu provided with this kit warns the user, "use care when removing guidewire.If resistance is encountered, remove guidewire and catheter together as a unit.Use of excessive force may damage catheter or guidewire".The report that the guidewire kinked during use was confirmed through examination of the returned sample.The guidewire had one kink present in its body.The returned guidewire met all relevant dimensional and functional requirements, and the investigation did not identify any manufacturing related issues.Based on the condition of the guide wire and the report that the damage was observed during use, unintentional use error 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 "guidewire was kinked when taken out of the tray.Explained that this has happened approximately 5 times over the past year".This was found prior to use.There was no patient involvement.Associated mdr numbers include: 9680794-2025-00862 and 9680794-2025-00863.

• Brand Name: ARROW RAD ART:20GAX3.81CM / ART LINE:20GAX12CM
• 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: 23391546
• Report Number: 9680794-2025-00863
• Device Sequence Number: 9871747
• Product Code: DQX
• UDI-Device Identifier: 10801902118001
• UDI-Public: (01)10801902118001(11)250416(17)270831(10)33F25C0154(21)
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2025

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: ASK-04500-HF-S
• Device Lot Number: 33F25C0154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2025
• 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