MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MAC KIT: 2-L 9 FR DISTAL X 11.5 CM AGB; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number	CDC-21242-XCN1A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "we have a kit that had a broken component if it when opened." this was found prior to use.There was no patient involvement.The user changed to a new device to complete the procedure.
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The photo shows the guidewire advanced within the straightener tube and a kink in the guidewire body.The complaint of a kinked guidewire was able to be confirmed by the photo, however, a complete visual inspection to determine the cause of the damage could not be performed as no sample was returned for analysis.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, "do not use if package is damaged".Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "we have a kit that had a broken component if it when opened." this was found prior to use.There was no patient involvement.The user changed to a new device to complete the procedure.

• Brand Name: ARROW MAC KIT: 2-L 9 FR DISTAL X 11.5 CM AGB
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLA
• 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: 23278496
• Report Number: 9680794-2025-00836
• Device Sequence Number: 12152333
• Product Code: MSD
• UDI-Device Identifier: 10801902179286
• UDI-Public: (01)10801902179286(11)250429(17)261130(10)33F25A0132(21)
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K111117
• 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): 09/19/2025

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-21242-XCN1A
• Device Lot Number: 33F25A0132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2025
• 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