MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 2-LUMEN 7FR X 20CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number ASK-17702-KR

Device Problems Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2024

Event Type  malfunction  

Event Description

It was reported that the user was unable to insert the swg into the needle and the catheter because of resistance during the test before use.Therefore, a new kit was used instead.The returned device was kinked, this is a reportable malfunction.

Manufacturer Narrative

Qn# (b)(4).

Manufacturer Narrative

(b)(4).The customer returned one guide wire assembly for analysis.The reported needle was not returned.Definite signs of use were observed on the returned sample.Visual analysis revealed that the guide wire contained one kink on the distal j-bend and a slight bend towards the proximal end.Microscopic examination confirmed the damage and revealed that both proximal and distal welds were full and spherical.Visual analysis of the needle could not be performed as it was not returned for analysis.The kinks in the guide wire measured 20mm and 593mm from the proximal tip.The overall length of the guide wire measured 603mm which is within the specification limits of 596mm-604mm per the guide wire product drawing.The outer diameter of the guide wire measured 0.804mm which is within the specification limits of 0.788-0.826mm per the guide wire product drawing.Dimensional inspection of the needle could not be performed as it was not returned for analysis.The guide wire was functionally tested per the instructions for use (ifu) provided with this kit, which instructs the user, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle.".The guide wire was threaded through a lab inventory 18ga introducer needle/arrow raulerson syringe (ars) subassembly as well as through a lab inventory catheter.The guide wire passed through all the components with little to no resistance.Functional inspection of the needle could not be performed as it was not returned for analysis.A manual tug test confirmed that both welds were full and spherical.A device history record review was performed with no relevant findings.The ifu provided with this kit informs the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.".The customer report of a kinked guide wire was confirmed through the complaint investigation of the returned guide wire.However, the report of resistance with the needle could not be evaluated as the needle was not returned.The guide wire contained multiple kinks/bends.Despite this, the guide wire passed all relevant dimensional and functional requirements, and a device history record review revealed no relevant findings.Based on the customer report and the sample received, and without the needle returned, the potential root cause cannot be determined at this time.Teleflex will continue to monitor and trend on reports of this nature.

Event Description

It was reported that the user was unable to insert the swg into the needle and the catheter because of resistance during the test before use.Therefore, a new kit was used instead.The returned device was kinked.

• Brand Name: ARROW CVC KIT: 2-LUMEN 7FR X 20CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• 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: 18561450
• MDR Text Key: 333451443
• Report Number: 3006425876-2024-00088
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/22/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: ASK-17702-KR
• Device Lot Number: 71F22G2586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 01/23/2024
• Supplement Dates Manufacturer Received: 02/07/2024
• Supplement Dates FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1