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

Catalog Number	CU-25122-F
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "(b)(6) 2025, when the guidewire was pulled out, the swg was found unraveled.They changed to a new one to resolve the issue.No harm for the patient.The patient condition is fine.No medical intervention was required.".
Event or Problem Description
It was reported that: "(b)(6) 2025, when the guidewire was pulled out, the swg was found unraveled.They changed to a new one to resolve the issue.No harm for the patient.The patient condition is fine.No medical intervention was required.".
Additional Manufacturer Narrative
(b)(4).The report that the guide wire unravelled was confirmed through examination of the returned sample.The customer provided one image showing a catheter and a guide wire and returned one guidewire for investigation.The catheter was not returned for evaluation.Signs of use were observed on the guide wire.Visual and microscopic examination identified unravelling from the proximal weld, multiple kinks along the guide wire body, and a core wire break adjacent to the proximal weld.The distal weld was observed to be full and spherical.Functional testing showed that the undamaged portion of the guide wire advanced without resistance, while resistance was encountered at the kinked and unravelled region, preventing further advancement.Dimensional inspection of the guide wire met applicable specification requirements.A review of the device history record did not identify any manufacturing-related issues.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.This internal specification is higher than required standard of 2.2 pounds force for this size wire.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Based on the observed condition of the guide wire and the information available, the damage is consistent with use-related mechanical stress.However, the probable cause could not be definitively determined without evaluation of the catheter involved in the event.Teleflex will continue to monitor and trend reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• Common Device Name: CATHETER PERCUTANEOUS
• 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: 24065745
• Report Number: 3006425876-2026-00023
• Device Sequence Number: 15799614
• Product Code: DQY
• UDI-Device Identifier: 00801902100276
• UDI-Public: (01)00801902100276(11)250804(17)270623(10)71F25G0845(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K862056
• 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): 12/22/2025

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 Catalogue Number: CU-25122-F
• Device Lot Number: 71F25G0845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2025
• 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