MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 4 FR X 5 CM; CATHETER PERCUTANEOUS

Catalog Number CS-12402

Device Problems Material Separation (1562); Material Twisted/Bent (2981)

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

Event Date 01/10/2024

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported that" (b)(6) 2024, the swg was found separated during use on the patient.The returned device was found to be kinked.The patient was reported as fine post the procedure.

Manufacturer Narrative

Qn# (b)(4).The customer provided two photos for evaluation.The complaint of a kinked guide wire was confirmed through visual inspection of the photos.The customer returned one opened cvc set with multiple components, including one guide wire in its assembly tubing for evaluation.Visual inspection revealed two kinks in the guide wire body.Microscopic examination confirmed the damage.Both welds were present and observed to be full and spherical.The kinks in the guide wire were located 9mm and 361mm from the distal end.The guide wire length measured 454mm which is within the specifications of 449.2mm-458.8mm per product drawing.The guide wire outer diameter measured 0.450mm which is within the specifications of 0.432-0.457 per product drawing.Functional inspection of the guide wire was performed per the instructions for use (ifu) provided with the kit which states, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the undamaged portions of the guide wire was threaded through a lab inventory arrow raulerson syringe (ars) and lab inventory introducer needle with no resistance.A manual tug test confirmed the distal and proximal welds were intact.A device history record review was performed with no relevant findings.The 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." the customer report of a kinked guide wire was confirmed through complaint investigation of the returned sample.Visual inspection revealed two kinks in the guide wire.The returned guide wire met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.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.

Event Description

It was reported that on (b)(6) 2024, the swg was found separated during use on the patient.The returned device was found to be kinked.The patient was reported as fine post the procedure.

• Brand Name: ARROW CVC SET: 2-LUMEN 4 FR X 5 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: 18660395
• MDR Text Key: 334786893
• Report Number: 3006425876-2024-00167
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 01/10/2024

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-12402
• Device Lot Number: 71F21D2306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/10/2024
• Initial Date FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2021
• 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.