MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 12 FR X 16 CM; CATHETER PERCUTANEOUS

Catalog Number CS-12123-F

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

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

Event Date 01/12/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

The complaint is reported as: "the doctor was found resistance when a guidewire was inserted through the introducer needle, but the guidewire could inserted into the patient finally.Then, needle was withdrawn and inserted the catheter through the guidewire.The catheter was placed successfully but the guidewire was kinked and damaged when it was removed.The central core wire of the guidewire was found broken, finally, the doctor removed the whole guidewire slowly by pulling the spring coil slowly." it was reported the guidewire and catheter were removed together and an x-ray was checked.No patient injury or harm reported.No medical intervention required.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer returned one guide wire for analysis.No obvious signs of use were observed on the guide wire.Visual analysis revealed the guide wire was unraveled from the distal weld and kinked in multiple locations along the body.The core wire distal j-bend was misshapen but intact.Microscopic examination confirmed the core wire was broken adjacent to the distal weld and that the weld was present at the end of the coil wire.Both welds appeared full and spherical.Visual analysis of the catheter could not be performed as it was not returned for analysis.The major kinks in the guide wire measured 305mm, 352mm, 379mm, and 415mm from the proximal end.The overall length of the coil wire measured 598mm which is within the specification limits of 596-604 mm per guide wire product drawing; therefore no pieces of the core wire appear to be missing.The outer diameter of the guide wire measured 0.849mm which is within the specification limits of 0.838-0.877 mm per guide wire product drawing.Functional inspection of the guide wire could not be performed for this complaint investigation due to the damage to the returned guide wire.A manual tug test confirmed that the proximal weld was intact.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this product describes suggested techniques to minimize the likelihood of guide wire damage during use.The ifu cautions that if resistance is encountered when attempting to remove the spring-wire guide after catheter placement, the spring-wire may be kinked about the tip of the catheter within the vessel which may result in undue force being applied resulting in spring wire guide breakage.If resistance is encountered, withdraw the catheter relative to the spring-wire guide about 2-3 cm and attempt to remove the spring-wire guide.If resistance is again encountered, remove the spring-wire guide and catheter simultaneously.The report that the guide wire was unraveled was confirmed through examination of the returned sample.The guide wire core wire was broken adjacent to the distal weld.Dimensional inspection and a device history record review did not reveal any evidence of a manufacturing related issue.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.This internal specification is higher than the bs en iso 11070:2014 standard of 2.2 pounds force for this size wire.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 contributed to this event, however, the probable cause of guide wire and catheter resistance could not be determined based upon the information provided and without the catheter being returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The complaint is reported as: "the doctor was found resistance when a guidewire was inserted through the introducer needle, but the guidewire could inserted into the patient finally.Then, needle was withdrawn and inserted the catheter through the guidewire.The catheter was placed successfully but the guidewire was kinked and damaged when it was removed.The central core wire of the guidewire was found broken, finally, the doctor removed the whole guidewire slowly by pulling the spring coil slowly." it was reported the guidewire and catheter were removed together and an x-ray was checked.No patient injury or harm reported.No medical intervention required.The patient's condition is reported as fine.

• Brand Name: ARROW CVC SET: 3-LUMEN 12 FR X 16 CM
• Type of Device: CATHETER PERCUTANEOUS
• 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: 16352525
• MDR Text Key: 309306887
• Report Number: 3006425876-2023-00149
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/13/2023

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 Operator: Health Professional
• Device Catalogue Number: CS-12123-F
• Device Lot Number: 71F19L2305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/13/2023
• Initial Date FDA Received: 02/10/2023
• Supplement Dates Manufacturer Received: 02/24/2023
• Supplement Dates FDA Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2019
• 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