MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM ANTE; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number	CS-15192-VFIE
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "during the insertion procedure, resistance was observed while advancing the catheter and procedure could not be completed.".There was delay in treatment and no harm occurred to the patient due to the catheter.The catheter was replaced, and the procedure was completed successfully.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "during the insertion procedure, resistance was observed while advancing the catheter and procedure could not be completed.".There was delay in treatment and no harm occurred to the patient due to the catheter.The catheter was replaced, and the procedure was completed successfully.
Additional Manufacturer Narrative
Qn (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and a potential finding was identified.As no sample was returned for investigation, it could not be determined if the finding was relevant to the reported event.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one vectorflow chronic hemodialysis antegrade kit for analysis.Visual inspection revealed no signs of use in the form of biological matter.The cuff on the catheter was slightly worn.No other defects or anomalies were observed on any other portion of the returned device.The outer diameter of the catheter body measured 0.207" which is within the specification limits of 0.1999"-0.209" per the catheter body product drawing.The length of the catheter body from the juncture hub to the distal tip measured 24.1cm which is within the specification limits of 23.3cm - 24.7cm per the catheter assembly product drawing.The returned catheter was functionally tested per the instructions for use (ifu) provided with this kit.The ifu states, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." a lab inventory syringe filled with water was used to flush each extension line of the returned catheter.No leaking or abnormalities were observed.A device history record review was performed, and there was one potential finding; however, it was determined that the finding was not relevant to the reported event.The ifu provided with this kit warns 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 customer report of catheter difficult to advance could not be confirmed through investigation of the returned sample.Visual analysis revealed the cuff on the catheter was slightly worn.No other defects or anomalies were observed on any other portion of the returned device.The device passed dimensional and functional testing.The catheter outer diameter and length were within specification.Water was flushed through both luer hubs with no resistance.Additional information was received.No harm occurred to the patient.The catheter was replaced.The user observed no physical damage to the catheter.A device history record review was performed, and no relevant findings were identified.Based on the customer report and sample received, no problem was found with the returned sample.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "during the insertion procedure, resistance was observed while advancing the catheter and procedure could not be completed.".There was delay in treatment and no harm occurred to the patient due to the catheter.The catheter was replaced, and the procedure was completed successfully.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM ANTE
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21583343
• Report Number: 9680794-2025-00234
• Device Sequence Number: 15670583
• Product Code: MSD
• UDI-Device Identifier: 10801902127195
• UDI-Public: (01)10801902127195(11)240507(17)270430(10)33F24D1001(21)
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K141051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/24/2025

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-15192-VFIE
• Device Lot Number: 33F24D1001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 04/11/2025; 11/19/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 04/21/2025; 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2024
• 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; NOT REPORTED
• Patient Sex: Unknown