MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 16 GA X 8" (20 CM); CATHETER,INTRAVASCULAR,THERAP

Catalog Number CS-24301-E

Device Problems Difficult to Advance (2920); Material Deformation (2976)

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

Event Date 01/14/2022

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported the dilator was difficult to advance in the patient.No patient harm was reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer returned one dilator and guidewire assembly for analysis.No definite signs of use were observed.Visual analysis of the returned dilator revealed the tip was split and frayed.This damage is consistent with undue force being applied to the dilator during an attempted insertion.The dilator body length from the hub to the distal tip 99mm which is within the specification of 95.2mm - 108mm per the dilator product drawing.The dilator outer diameter measured 2.31mm which is within the specification limits of 2.286mm-2.336mm per the dilator extrusion product drawing.The dilator inner diameter at the proximal end measured 0.9652mm which is within the specification of 0.9144mm - 0.9652mm per the dilator extrusion product drawing.The returned guide wire with a diameter of.826mm was passed through the distal end of the returned dilator.The guide wire passed through the dilator with little to no resistance.Performed per the instructions for use provided with the kit which states "use tissue dilator to enlarge tissue tract to the vein as required.Follow the angle of the guidewire slowly through the skin." a device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user "use vessel dilator to enlarge site as required.Warning: do not leave vessel dilator in place as an indwelling catheter to minimize the risk of possible vessel wall perforation".The customer report of a damaged dilator tip was able to be confirmed via complaint investigation of the returned sample.The dilator tip was split and frayed at the distal tip.This damage is consistent with undue force being applied to the dilator during an attempted insertion.The returned dilator met all relevant functional/dimensional requirements, and a device history record review performed with no relevant findings.Based on the results of this investigation and the customer report that the damage occurred during use, 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 the dilator was difficult to advance in the patient.No patient harm was reported.The patient's condition is reported as fine.

• Brand Name: ARROW CVC SET: 16 GA X 8" (20 CM)
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• 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: 14779674
• MDR Text Key: 295151818
• Report Number: 3006425876-2022-00606
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K900263
• 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: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 02/16/2023
• Device Catalogue Number: CS-24301-E
• Device Lot Number: 71F21C1123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2021
• 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