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

Model Number IPN918765

Device Problems Difficult to Remove (1528); Material Separation (1562); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 01/24/2024

Event Type  malfunction  

Event Description

It was reported "when withdrawing of the swg, separation between the hard part of the guide and the swg kinked." the swg was removed.The patient's current condition is reported as "unknown".

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The customer returned one guide wire, catheter, and tray with lidstock for analysis.No other components were returned.Signs of use in the form of biological material was observed.Visual analysis revealed that the guide wire was unraveled from the proximal end and contained multiple kinks along the body.Microscopic examination confirmed the damage and revealed that the core wire had separated directly adjacent to the proximal weld.Both welds were full and spherical.The distal j-bend was misshapen but intact.The major kinks in the guide wire measured 335mm, 394mm, and 410mm from the distal end.The overall length of the guide wire core wire measured 596mm, which is within the specification of 596mm-604mm per guide wire product drawing; therefore, no piece of the core wire appears to be missing.The outer diameter of the guide wire measured 0.798mm which is within the outer diameter specification of 0.788-0.826mm per product drawing.The undamaged end (distal end) of returned guide wire was inserted through a lab inventory arrow raulerson syringe (ars) and introducer needle subassembly.Little to no resistance was observed in the undamaged portions of the guide wire as it passed through the subassembly.Performed per ifu statement, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".The undamaged end of the guide wire was also threaded through the returned catheter and the undamaged portions experienced little to no resistance.A manual tug test confirmed that the distal weld was intact.A device history record review was performed, and no relevant findings were identified to suggest a manufacturing issue.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 unraveled was confirmed through examination of the returned sample.Visual analysis revealed that the core wire was broken adjacent to the proximal weld.The guide wire met all functional/dimensional requirements during investigation testing.No manufacturing defects were found during this investigation.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds of 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 caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported "when withdrawing of the swg, separation between the hard part of the guide and the swg kinked." the swg was removed.The patient's current condition is reported as "unknown".

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 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: 18707238
• MDR Text Key: 335536454
• Report Number: 3006425876-2024-00119
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K862056
• 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: 01/24/2024

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 Model Number: IPN918765
• Device Catalogue Number: CV-15703
• Device Lot Number: 71F23D3073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/14/2024
• Supplement Dates Manufacturer Received: 02/27/2024
• Supplement Dates FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2023
• 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: NONE REPORTED; NONE REPORTED