MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 5 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number	ES-04301
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that"on (b)(6) 2025, during the operation, the swg can't inserted into ars, after adjust the swg can't inserted into." 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 lidstock and guide wire assembly for analysis.Neither the arrow raulerson syringe (ars) nor the introducer needle were returned for analysis.No obvious signs of use were observed.Visual analysis revealed a kink towards the distal end of guidewire and offset coils at the distal end of the guide wire.Visual analysis could not be performed on the ars or the introducer needle as they were not returned.The kink measured 365mm from the proximal end.The guide wire measured 602mm, which is within the specification limits of 596mm-604mm per the guide wire product drawing.The guide wire outer diameter measured 0.790mm, which is within the specification limits of 0.788mm-0.826mm per the guide wire product drawing.The guide wire was inserted through a lab inventory ars/introducer needle subassembly.The guide wire passed with no resistance.Performed per ifu statement, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".Functional analysis could not be performed on the ars or the introducer needle involved with this complaint as they were not returned.A manual tug test confirmed that the distal and proximal weld were secure and intact.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage." the ifu also states, "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 a kinked guidewire was confirmed through investigation of the returned sample.Visual analysis of the guidewire revealed that it was kinked.Despite this, the guidewire passed all relevant dimensional requirements.Functional testing with a lab inventory ars/18ga introducer needle confirmed resistance at the kinked section of the guide wire; however, all functional sections were able to pass with no issue.A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample received, the failure appears consistent with damage due to undue force applied during insertion; however, without the ars and insertion needle returned for analysis, the root cause cannot be determined at this time.Teleflex will continue to monitor and trend for reports.
Event or Problem Description
It was reported that" on (b)(6) 2025, during the operation, the swg can't inserted into ars, after adjust the swg can't inserted into." 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".

• Brand Name: ARROW CVC SET: 5 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23278363
• Report Number: 3006425876-2025-00992
• Device Sequence Number: 15643871
• Product Code: DQY
• UDI-Device Identifier: 10801902122756
• UDI-Public: (01)10801902122756(11)241115(17)291031(10)71F24L0201(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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2025

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
• Device Catalogue Number: ES-04301
• Device Lot Number: 71F24L0201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2024
• 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