MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM; CATHETER HEMODIALYSIS NON IMPL

Catalog Number	CU-22122-F
Medical Device Problem Codes	Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "the occlusion of the central lumen of ars prevented the guidewire from passing through smoothly, resulting in guidewire deflection.The same issue persisted even after the catheter was replaced, yet the procedure was ultimately completed successfully.The second swg/ars that had resistance but was able to complete the procedure was found kinked.There was no reported patient harm or consequence." associated complaint 3006425876-2026-00050.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and potential findings were identified; however, as no sample was returned for investigation, it could not be determined if the findings were relevant to the reported event.Without the device to evaluate the complaint could not be confirmed and 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: ", the occlusion of the central lumen of ars prevented the guidewire from passing through smoothly, resulting in guidewire deflection.The same issue persisted even after the catheter was replaced, yet the procedure was ultimately completed successfully.The second swg/ars that had resistance but was able to complete the procedure was found kinked.There was no reported patient harm or consequence." associated complaint 3006425876-2026-00108 and 3006425876-2026-00050.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM
• Common Device Name: CATHETER HEMODIALYSIS NON IMPL
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24143137
• Report Number: 3006425876-2026-00108
• Device Sequence Number: 8998328
• Product Code: MPB
• UDI-Device Identifier: 00801902100252
• UDI-Public: (01)00801902100252(11)230206(17)250112(10)71F23A2932(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K993933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2025

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 Expiration Date: 01/12/2025
• Device Catalogue Number: CU-22122-F
• Device Lot Number: 71F23A2932
• 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: 12/26/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2023
• 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