MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM; CATHETER HEMODIALYTSIS NON IMP

Catalog Number	CS-25122-F
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "on (b)(6) 2026, during catheterization in the intensive care unit of the (b)(6) hospital, it was discovered that the guidewire had become unraveled and could not be inserted, so a new catheter was used instead.".
Additional Manufacturer Narrative
(b)(4).The customer-reported unravelled guidewire confirmed through visual analysis of the returned sample.The customer provided a photo and returned one guide wire for evaluation.Biological material was observed on the guidewire.The guidewire identified three kinks in the guidewire, with one kink located adjacent to the core wire separation.The guidewire exhibited unravelling with separation of the core wire in the distal region.Both separated portions of the core wire remained attached to their respective welds.Dimensional analysis confirmed the returned sample does not match the customer reported finished good.The dimensional discrepancy in guidewire length indicates that the returned sample does not match with the specification associated with the reported material number.This indicates that either an incorrect material number was reported or a different product was returned for evaluation.A device history record review was performed, and no relevant findings were identified.No manufacturing defects were found during this investigation, and a device history record review did not identify any manufacturing-related issues.However, based on the discrepancy between the reported finished good and the returned devices, the root cause could not be determined.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "on (b)(6) 2026, during catheterization in the intensive care unit of (b)(6), it was discovered that the guidewire had become unraveled and could not be inserted, so a new catheter was used instead.".

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• Common Device Name: CATHETER HEMODIALYTSIS NON IMP
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24505122
• Report Number: 3006425876-2026-00263
• Device Sequence Number: 16073897
• Product Code: MPB
• UDI-Device Identifier: 00801902100207
• UDI-Public: (01)00801902100207(11)250411(17)270207(10)71F25D0387(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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

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 Catalogue Number: CS-25122-F
• Device Lot Number: 71F25D0387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2025
• 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