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	11/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that (b)(6) 2025, after insertion, the swg unravel after into the vessel, changed a new one.The patient condition is fine.No harm for the patient.They changed a new one to resolve the issue.No medical intervention was required.No more other information will be required.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer report of an unravelled guidewire was confirmed through examination of the returned sample.The customer returned a guidewire and 2-lumen hemodialysis catheter for evaluation.The guidewire was returned partially advanced through the catheter.Moderate force was required to remove the guidewire from the catheter due to buildup of biological material.The core wire had separated adjacent to the proximal weld.The guidewire and catheter met all dimensional requirements.The catheter met all relevant functional requirements, and a device history record review did not reveal any relevant findings.A device history record review was performed, and no relevant findings were identified.Arrow guidewires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.This internal specification is higher than the 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 guidewire kinking.Guidewire breakage may occur if a force greater than the design specification is applied during removal.Based on these circumstances, unintentional use error caused or contributed to this event.
Event or Problem Description
It was reported that"(b)(6) 2025, after insertion, the swg unravel after into the vessel, changed a new one.The patient condition is fine.No harm for the patient.They changed a new one to resolve the issue.No medical intervention was required.No more other information will be required.".

• 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: 23680053
• Report Number: 3006425876-2025-01102
• Device Sequence Number: 15904468
• Product Code: DQY
• UDI-Device Identifier: 00801902100276
• UDI-Public: (01)00801902100276(11)250102(17)261106(10)71F24M0759(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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2025

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: 71F24M0759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2025
• 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