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	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "according to the doctor's order, rasitol 100mg was administered stat iv, and cvc placement was assisted as needed based on the patient's condition for hemodialysis.During the emergency physician's assistance in catheter placement, it was found that the guide wire could be inserted into the needle but could not be smoothly removed." the device was removed and replaced there was no patient harm or injury.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one arrow advancer, swg, and an introducer needle for analysis.Signs of use were observed on the returned components.Visual analysis revealed kinking along the guidewire body.Further analysis revealed that the distal j-bend was misshapen.Microscopic examination confirmed the kink and revealed offset coils at the distal end.The core wire was broken directly adjacent to the distal weld.The proximal weld was full and spherical.After performing functional testing, resistance was encountered within the needle cannula due to the offset coils.The kinks on the guidewire measured 564mm, 653mm, and 665-682mm from the proximal end.The guidewire length measured 682mm, which is within the specification limits of 678mm - 688mm per the guidewire product drawing.The guidewire outer diameter measured 0.84mm, which is within the specification limits of 0.838mm - 0.877mm per the guidewire product drawing.The needle cannula outer diameter measured 0.0500" , which is within the specification limits of 0.0495" - 0.0505" per the needle cannula product drawing.The inner diameter of the cannula at the distal end measured 0.041", which is within the specification limits of 0.041"-0.043" per the cannula product drawing.The returned guidewire was inserted through the returned introducer needle and a lab inventory arrow raulerson syringe (ars) subassembly.Major resistance was encountered at the location of kinking and offset coils.Subsequently, the undamaged proximal end of the guidewire was tested at a location with no damage, and no resistance was encountered.Performed per ifu statement, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".A manual tug test confirmed that the proximal weld was full and spherical.A device history record review was performed and no relevant findings were identified.The ifu provided with the kit informs the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested".The report of the guidewire not being able to be smoothly removed was confirmed through investigation of the returned sample.Visual analysis revealed kinking and offset coils at the distal end of the guidewire.Microscopic analysis revealed that the core wire was broken adjacent to the distal weld.Functional testing revealed resistance when the damaged portion of the guidewire was attempted to pass through the introducer needle.Despite the damage, the guidewire and the needle met all relevant dimensional requirements.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 bs en iso 11070:2014 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.Based on the customer report that the damage was observed during use and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• 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: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23533084
• Report Number: 3006425876-2025-01086
• Device Sequence Number: 9065457
• Product Code: MPB
• UDI-Device Identifier: 00801902100207
• UDI-Public: (01)00801902100207(11)240421(17)260312(10)71F24D0583(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Report Date (Section B): 11/04/2025

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: 03/12/2026
• Device Catalogue Number: CS-25122-F
• Device Lot Number: 71F24D0583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2024
• 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
• Patient Sex: Unknown