MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB+; CATHETER INTRAVASCULAR THERAP

Catalog Number	AK-45703-P1A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "said guidewire was kinked when taken out of the tray before insertion." there was no patient involvement.
Event or Problem Description
It was reported that "said guidewire was kinked when taken out of the tray before insertion." there was no patient involvement.
Additional Manufacturer Narrative
(b)(4).The customer returned one guidewire and one lidstock for analysis.Signs of use in the form of biological material were observed.Visual analysis revealed one kink towards the proximal end of the guidewire.Microscopic examination confirmed the distal and proximal welds were spherical and intact.The kink in the guidewire was located 146 mm from the proximal end.The overall guidewire length measured 602 mm, which is within the specification limits of 596 mm - 604 mm per the guidewire product drawing.The guidewire outer diameter measured.800 mm, which is within the specification limits of 0.788 mm - 0.826 mm per the guidewire product drawing.The guidewire was functionally tested per the product instructions for use (ifu) which instructs the user to "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the guidewire was advanced through a lab inventory arrow raulerson syringe (ars) with and without a lab inventory 18 ga introducer needle attached.The undamaged portion of the guidewire passed with 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 , "warning: do not apply undue force on guidewire to reduce risk of possible breakage." the report of a damaged guidewire was confirmed through visual examination of the returned sample.One kink was observed towards the proximal end of the guidewire.The guidewire passed all relevant dimensional and functional requirements.A device history record review was performed with no 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 PI CVC KIT: 3-L 7 FR X 20 CM AGB+
• Common Device Name: CATHETER INTRAVASCULAR THERAP
• 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: 23391660
• Report Number: 9680794-2025-00865
• Device Sequence Number: 10179169
• Product Code: FOZ
• UDI-Device Identifier: 50801902114803
• UDI-Public: (01)50801902114803(11)250507(17)260531(10)33F25C0341(21)
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• 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 Expiration Date: 05/31/2026
• Device Catalogue Number: AK-45703-P1A
• Device Lot Number: 33F25C0341
• 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: 10/28/2025
• 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: 05/07/2025
• 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