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

Catalog Number CS-25703-E

Device Problems Unraveled Material (1664); Physical Resistance/Sticking (4012)

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

Event Date 10/24/2023

Event Type  malfunction  

Event Description

It was reported that: the swg was hard to advance and was kinked.A new set was needed.The issues was identified during use on patient but there was no reported patient consequence.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: the swg was hard to advance and was kinked.A new set was needed.The issues was identified during use on patient but there was no reported patient consequence.

Manufacturer Narrative

(b)(4).The customer report of an unravelled guide wire was confirmed through complaint investigation of the returned sample.The customer returned multiple components of a cvc kit, including one guide wire assembly, arrow raulerson syringe (ars), and catheter for evaluation.Signs-of-use were observed on the returned components.Visual inspection of the guide wire revealed multiple kinks along the guide wire body.The guide wire coil wire was also observed to be unravelled from the core wire at the distal weld.Microscopic examination confirmed the damage and revealed that both welds were present and spherical.Visual inspection of the ars revealed no obvious defects or anomalies.The kinks in the guide wire measured 357mm and 391mm via calibrated ruler from the proximal end.The overall length of the guide wire core wire measured 600mm via calibrated ruler, which was within the specifications of 596-604mm per product drawing.The guide wire outer diameter (od) measured 0.803mm via calibrated caliper, which was within the specifications of 0.788-0.826mm per product drawing.Dimensional inspection of the ars was not required as part of this complaint investigation.Functional inspection of the returned components was performed per the product ifu which states, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." major resistance was experienced at the location of the kinking.The undamaged portions of the guide wire passed with little to no resistance.A manual tug test confirmed the proximal weld was intact.The instructions-for-use (ifu) provided with this kit warns 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." a device history record review was not required as part of this complaint investigation.Arrow guide wires of this size were designed and manufactured to withstand a tensile force of 2.75 pounds force.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Based on these circumstances, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18319197
• MDR Text Key: 330466790
• Report Number: 3006425876-2023-01240
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/16/2023

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
• Device Lot Number: 71F22L0906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 01/04/2024
• Supplement Dates FDA Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2022
• 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
• Treatment: NOT REPORTED; NOT REPORTED