MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-25703-E

Device Problems Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)

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

Event Date 01/16/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "swg hard to advance.The issue occurred on 4 different patients.There was no reported patient harm." associated complaints 3006425876-2024-00259, 3006425876-2024-00264 and 3006425876-2024-00260.

Event Description

It was reported that "swg hard to advance.The issue occurred on 4 different patients.There was no reported patient harm." associated complaints 3006425876-2024-00259, 3006425876-2024-00264 and 3006425876-2024-00260.

Manufacturer Narrative

(b)(6) the customer provided one image of multiple guide wire assemblies packaged in a bag.Kinking in at least one guide wire body is visible.The customer returned one guide wire assembly for analysis.The cap was not included.Definite signs of use in the form of biological material were observed.Visual analysis of the guide wire revealed that it contained multiple kinks towards the distal end of the body.The distal j-bend was significantly misshapen but intact.Microscopic examination confirmed the kinks and revealed that both welds were present and spherical.The kinks on the guide wire measured 585mm and 590mm from the proximal weld.The overall length of the guide wire measured 602 mm which is within the specification of 596mm-604mm per guide wire product drawing.The outer diameter of the guide wire measured 0.79mm, which is within the specification of 0.788mm-0.826mm per guide wire product drawing.The guide wire was advanced through a lab inventory ars and a lab inventory 18ga introducer needle to functionally test the guide wire.Resistance was observed at the kinking; however, the undamaged portion of the guide wire was able to pass as expected.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 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 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 that the guide wire kinked during use was confirmed through examination of the returned sample.The guide wire contained multiple kinks towards the distal end.All relevant dimensional and functional requirements were met, and a device history record review did not identify any manufacturing related issues.Based on the condition of the guide wire 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.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• 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: 18797079
• MDR Text Key: 336513519
• Report Number: 3006425876-2024-00261
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K900263
• 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: 02/26/2024

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: CS-25703-E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 02/28/2024
• Supplement Dates Manufacturer Received: 03/14/2024
• Supplement Dates FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: NOT REPORTED; NOT REPORTED