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 Difficult to Advance (2920); Material Twisted/Bent (2981)

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

Event Date 09/11/2023

Event Type  malfunction  

Event Description

It was reported that "swg hard to advance on 4 different patients.No patient harm." the returned devices were noted to be kinked.Associated complaints 3006425876-2024-00260, 3006425876-2024-00261 and 3006425876-2024-00264.

Manufacturer Narrative

(b)(4).

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 also returned one guide wire assembly for analysis.The guide wire straightener tube and cap were not returned for analysis.Definite signs of use in the form of biological material were observed.Visual analysis of the guide wire revealed that it was kinked in multiple locations along the entire length 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 major kinks on the guide wire measured 165mm and 575mm 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 0.80mm, 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 was kinked along the length of the body.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.

Event Description

It was reported that "swg hard to advance on 4 different patients.No patient harm." the returned devices were noted to be kinked.Associated complaints , 3006425876-2024-00260, 3006425876-2024-00261 and 3006425876-2024-00264.

• 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: 18795521
• MDR Text Key: 336513421
• Report Number: 3006425876-2024-00259
• 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

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: 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: Not provided
• 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