MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 4 FR X 13 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-14402
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the doctor found the swg kinked during used on the patient.They changed a new one to resolve the issue.No harm for the patient.The patient condition is fine.No medical intervention was required".
Event or Problem Description
It was reported that "the doctor found the swg kinked during used on the patient.They changed a new one to resolve the issue.No harm for the patient.The patient condition is fine.No medical intervention was required".
Additional Manufacturer Narrative
(b)(4).The customer returned one guidewire within its advancer for analysis.Obvious signs of use were observed on the guidewire in the form of biological material.The guidewire was observed to have several kinks/bends throughout the body.The distal j-bend was misshapen.Microscopic examination confirmed the kinks in the guidewire body.Both welds were present and were observed to be full and spherical.The major kinks in the guidewire were located at 131mm, 194mm, and 211mm from the proximal tip.Slight bends were measured between 133mm and 200mm from the proximal tip.The overall length of the guidewire measured 455mm , which is within the specification limits of 449.2mm - 458.8mm per guidewire product drawing.The outer diameter of the guidewire measured 0.45mm, which is within the specification limits of 0.432mm - 0.457mm per guidewire product drawing.The guide wire was functionally tested per the product instructions for use (ifu).The ifu provided with this kit instructs the user, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the guidewire was advanced through a lab inventory ars and a lab inventory 18ga introducer needle.Initially, major resistance was observed due to the buildup of biological material stuck to the distal tip of the guidewire.After the buildup was cleaned, the test was conducted again and the guidewire passed through the ars and needle with little to no resistance.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit describes suggested techniques to minimize the likelihood of guidewire damage during use.The instructions caution, "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 that the guidewire kinked during use was confirmed through complaint investigation of the returned sample.The guidewire had several kinks and bends throughout the body.The returned guidewire met all relevant dimensional/functional requirements, and a device history record review did not identify any manufacturing related issues.Based on the condition of the guidewire and the report that the damage was observed during use, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.

• Brand Name: ARROW CVC SET: 2-LUMEN 4 FR X 13 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: 20913745
• Report Number: 3006425876-2024-01202
• Device Sequence Number: 7824830
• Product Code: DQY
• UDI-Device Identifier: 00801902102140
• UDI-Public: (01)00801902102140(11)230403(17)280331(10)71F23C2024(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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2024

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-14402
• Device Lot Number: 71F23C2024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2024
• Supplement Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2023
• 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
• Patient Sex: Unknown