MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC/PSI KIT: 3-L 7FR X 16CM/8.5FR X 10CM; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number ASK-42703-PSI1

Device Problems Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)

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

Event Date 12/08/2022

Event Type  malfunction  

Event Description

It was reported "guide wire is stuck in the catheter, cannot be removed from it".No patient harm was reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer returned one guide wire and one 3-l cvc for analysis.The guide wire was returned inserted within the catheter.Signs of use in the form of dried biological material were observed on the returned components.The guide wire was removed from the catheter to further analyze.Visual inspection of the guide wire revealed one kink partway down its body.Microscopic examination confirmed the damage.Both welds were observed to be present and appeared full and spherical.Visual inspection of the catheter revealed no obvious defects or anomalies.The kink in the guide wire measured 264mm from the distal end.The total guide wire length measured 455mm, which is within the specifications of 450-458mm.The guide wire outer diameter (od) measured 0.873mm, which is within the specifications of 0.838-0.877mm.The catheter length measured 168mm, which is within the specifications of 157-177mm.The catheter body outer diameter (od) measured 0.09675", which is within the specifications of 0.094-0.098".The distal extension line outer diameter (od) 0.08555", which is within the specifications of 0.084"-0.088".The distal extension line inner diameter (id) measured 0.057" which is within the specifications of 0.055"-0.059".Functional inspection of the returned components was performed per the instructions-for-use (ifu) provided with the kit which states, "thread tip of catheter over guidewire.Sufficient guidewire length must remain exposed at hub end of catheter to maintain a firm grip on guidewire.Grasping near skin, advance catheter into vein with slight twisting motion." the guide wire was removed from the catheter with no resistance and was fully re-threaded through the catheter distal lumen with no resistance.A manual tug test confirmed the distal and proximal welds were intact.The guide wire product drawing, the catheter product drawing, the catheter extrusion product drawing, and the distal extension line extrusion product drawing were reviewed as part of this complaint investigation.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." the customer report of a kinked guide wire was confirmed through complaint investigation of the returned sample.The guide wire contained one kink in its body.The returned guide wire and catheter met all relevant functional and dimensional 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.

• Brand Name: ARROW CVC/PSI KIT: 3-L 7FR X 16CM/8.5FR X 10CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: victoria sandlin ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16435144
• MDR Text Key: 310246510
• Report Number: 9680794-2023-00175
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K071538
• 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: 02/20/2023

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 Expiration Date: 06/01/2024
• Device Catalogue Number: ASK-42703-PSI1
• Device Lot Number: 13F22J0156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2023
• Initial Date Manufacturer Received: 02/20/2023
• Initial Date FDA Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2024
• 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.