MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AHDC AGB KIT: 2-L 14 FR X 15 CM; CATHETER, HEMODIALYSIS, TRIPLE

Catalog Number	CDC-22142-XCN1A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "inserter observed a defect in the j-tip of the wire prior to use." there was no patient involvement.
Event or Problem Description
It was reported "inserter observed a defect in the j-tip of the wire prior to use." there was no patient involvement.
Additional Manufacturer Narrative
(b)(4) the customer provided two photos for analysis.The complaint of a kinked guidewire was confirmed by the photos, which show a kink in the distal j-bend of the guidewire.The customer also returned a guidewire within its advancer and lidstock for analysis.Obvious signs of use were observed on the sample.The guidewire advancer end cap was not returned.Visual examination revealed the coil wire on the distal j-bend of the guide wire was kinked, and the core wire was exposed.Microscopic examination revealed that both welds were full and spherical.Both welds were attached to the core wire.The kink in the guidewire was measured at 698mm from the proximal weld.The overall length of the guide wire measured 703mm, which is within the specification limits of 696mm -704mm per guidewire product drawing.The outer diameter of the guidewire measured 0.86mm, which is within the specification limits of 0.838mm - 0.889mm 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, "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 ars and 18ga introducer needle to functionally test the guidewire.The guidewire passed through with little to no resistance.A manual tug test confirmed the distal and proximal welds were fully secured and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit warns the user , "do not use if package is damaged." the report that the guidewire was kinked was confirmed through complaint investigation of the returned sample.A kink was observed on the distal j-bend of the guidewire body.The guidewire met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.During normal assembly, the kinked portion of the guidewire would be protected within the guidewire end cap of the advancer assembly, however, the end cap was not returned for evaluation.Based on the customer report and sample received, the potential root cannot be determined as it cannot be confirmed when the damage occurred.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW AHDC AGB KIT: 2-L 14 FR X 15 CM
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE
• 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: 22167616
• Report Number: 9680794-2025-00476
• Device Sequence Number: 20790797
• Product Code: NIE
• UDI-Device Identifier: 10801902213539
• UDI-Public: (01)10801902213539(11)250305(17)261031(10)33F25A0285(21)
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K143102
• 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): 05/16/2025

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: CDC-22142-XCN1A
• Device Lot Number: 33F25A0285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2025
• 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