MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 4-LUMEN 8.5FR X 16CM; CATHETER, PERCUTANEOUS

Catalog Number	CS-12854-E
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one guide wire assembly for analysis.It was noted that the advancer tubing and the guide wire cap were not returned.Signs of use in the form of biological material were observed inside the guide wire tubing and on the guide wire surface.Visual analysis revealed two kinks towards the distal end of the guide wire.Microscopic examination confirmed the damage and revealed that the distal and proximal welds were secure and intact.The kinks on the guide wire measured 475mm and 564mm from the proximal weld.The guide wire length measured 603mm, 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 returned guide wire was passed through a lab inventory arrow raulerson syringe (ars)/18ga introducer needle subassembly.The guide wire passed with minor resistance at the location of the kinks.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 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 a kinked guide wire was confirmed through analysis of the returned sample.Visual analysis revealed two kinks.Despite the damage, the guide wire met all relevant dimensional and functional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report 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.
Event or Problem Description
It was reported "faulty guidewire when inserting central line access to patient".

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 16CM
• 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 27560
• MDR Report Key: 21584889
• Report Number: 3006425876-2025-00283
• Device Sequence Number: 8868524
• Product Code: DQY
• UDI-Device Identifier: 00801902028983
• UDI-Public: (01)00801902028983(11)230426(17)280229(10)71F24B0499(21)
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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
• Report Date (Section B): 03/27/2025

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-12854-E
• Device Lot Number: 71F24B0499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2023
• 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