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

Catalog Number	CS-15122-F
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "(b)(6) 2025, before insertion, the doctor found swg kinked prior to the patient." the user changed to a new set to resolve the issue.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "(b)(6) 2025, before insertion, the doctor found swg kinked prior to the patient." the user changed to a new set to resolve the issue.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one guide wire assembly for analysis.Signs of use were observed on the guide wire and inside the tubing assembly, which contradicts the customer report that the defect was observed prior to use.The customer was contacted, and they reiterated that the defect was observed prior to use and any biological material is from exposure within the clinical setting.The guide wire was removed from the tubing and a kink was observed towards the distal end.Microscopic examination confirmed the damage and revealed that the distal j-bend was slightly misshapen.Further microscopic examination revealed that the distal and proximal welds were secure and intact.When assembled inside the guide wire tubing, the location of the kink would be located inside the blue straightener tube, protecting it from damage whilst inside the packaging.The kink on the guide wire measured 655mm from the proximal weld.The guide wire total length measured 683mm, which is within the specification limits of 678mm-688mm per the guide wire product drawing.The guide wire outer diameter measured 0.840mm, which is within the specification limits of 0.838mm-0.877mm per the guide wire product drawing.The guide wire was passed through a lab inventory arrow raulerson syringe (ars) and 18ga introducer needle.Despite the kinking, the guide wire was able to pass through both components with little to no issue.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 distal and proximal welds were secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use if package is damaged".The ifu also states, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The report that the guidewire was kinked was confirmed through complaint investigation of the returned sample.A kink was observed towards the distal end of the guidewire body.The guidewire met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.During normal assembly, the kinked portion of the guidewire would be protected within the guidewire tubing.Based on the customer report and sample received, the potential root cannot be determined as it is unknown if the damage occurred before or after the customer handled.Teleflex will continue to monitor and trend for complaints 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22142741
• Report Number: 3006425876-2025-00507
• Device Sequence Number: 8216125
• Product Code: MPB
• UDI-Device Identifier: 00801902100146
• UDI-Public: (01)00801902100146(11)240408(17)290331(10)71F24C1525(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): 05/13/2025

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: CS-15122-F
• Device Lot Number: 71F24C1525
• 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: 05/13/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2024
• 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; NOT REPORTED
• Patient Sex: Unknown