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 Codes	Difficult to Remove (1528); Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: " on (b)(6) 2025, when the icu doctor at (b)(6) hospital affiliated to (b)(6) implanted the device, the guidewire got stuck in the puncture needle and could not be withdrawn.Therefore, the guidewire and puncture needle had to be withdrawn together, and a new catheter was re-inserted for catheterization.The customer said the swg unraveled, no harm for the patient.The patient condition is fine.Associated complaints 3006425876-2025-01157.
Additional Manufacturer Narrative
(b)(4).The report of an unravelled guide wire was confirmed through examination of the customer supplied video; however, analysis of the returned samples revealed that they do not match the sample shown in the video.Furthermore, visual and dimensional analysis revealed that the returned samples do not match the components normally included within the reported finished good.Kinking was visible on the guide wires, but no unravelling or separation was observed.No manufacturing defects were found during this investigation.Arrow guide wires of the size normally included within the reported finished good 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 guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.A device history record review was performed on the reported finished good and no findings were identified.Based on these circumstances, the observed damage on the returned samples appears consistent with undue force applied during insertion; however, due to the discrepancies, the root cause cannot be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "(b)(6) 2025, when the icu doctor at (b)(6) hospital affiliated to (b)(6) university implanted the device, the guidewire got stuck in the puncture needle and could not be withdrawn.Therefore, the guidewire and puncture needle had to be withdrawn together, and a new catheter was re-inserted for catheterization.The customer said the swg unraveled, no harm for the patient.The patient condition is fine.Associated complaints 3006425876-2025-01157 and 3006425876-2025-01160.".

• 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: 23828925
• Report Number: 3006425876-2025-01160
• Device Sequence Number: 9277937
• 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): 11/20/2025

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: 12/11/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 01/05/2026
• 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