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 01/16/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).The report that the guide wire kinked during use was confirmed through examination of the returned sample.The guide wire had one kink towards the distal j-bend.The returned guide wire 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 guide wire and the report that the damage was observed during use, unintentional user 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.The issue occurred on 4 different patients.There was no reported patient harm." associated complaints 3006425876-2024-00259, 3006425876-2024-00261, 3006425876-2024-00264 and 3006425876-2024-00260.

Manufacturer Narrative

(b)(4).The customer provided one photo for analysis.The complaint of swg kinked was not able to be confirmed by the photo.The customer also returned one swg within its advancer for evaluation, however, the straightener tube and end cap from the assembly were not returned.Signs of use were observed on the sample.The guide wire was observed to have one kink towards the distal j-bend and another towards the center of the body.The distal j-bend was misshapen but intact.Microscopic examination confirmed the kinks in the guide wire body.Both welds were present and were observed to be full and spherical.The kinks in the guide wire were located 433 mm and 660 mm from the proximal tip.The overall length of the guide wire measured 684 mm which is not within the specification of 596-604 mm per guide wire product drawing.The outer diameter of the guide wire measured 0.845 mm which is not within the specification of 0.788-0.826 mm per guide wire product drawing.The dimensional discrepancy indicates the customer either returned the incorrect guide wire or reported the incorrect material number.The guide wire was advanced through a lab inventory ars and 18ga introducer needle to functionally test the guide wire.Resistance was met at the kinked portions of the guide wire; however, the undamaged portions passed through both components with little to no resistance.Performed per the instructions for use (ifu) statement, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through s yringe valves or into introducer needle." a manual tug test confirmed that both the distal and proximal welds were intact.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number taken from the sales history data of the customer.No relevant findings were identified.The ifu provided with the kit describes suggested techniques to minimize the likelihood of guide wire 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 of a kinked guide wire was confirmed through examination of the returned sample.The guide wire had two kinks on the body.However, the returned guide wire did not match dimensional specifications of the guide wire provided in the reported finished good which suggests the customer either returned the incorrect guide wire or reported the incorrect finished good.A device history record review based on sales history did not identify any manufacturing related issues.Based on these circumstances and the customer description , the root cause could not be determined due to the discrepancy between the reported device and the returned sample.Teleflex will continue to monitor and trend for reports of this nature.

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, 3006425876-2024-00261, 3006425876-2024-00264 and 3006425876-2024-00260.

• 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: 18806348
• MDR Text Key: 336578060
• Report Number: 3006425876-2024-00264
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801902102324
• UDI-Public: 00801902102324
• 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 Catalogue Number: CS-25703-E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 02/29/2024
• 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