Response to letter to the editor: Coiling of guidewire – Out of date Vascath Set
Thank you very much for the opportunity to reply to the letter from Dr Santhosh Babu. We are sorry to hear a problem occurred with a Vygon Dualyse Expert Catheter.
Unfortunately, Vygon (UK) Ltd was not contacted at the time of the incident. From correspondence with Dr Babu, we understand that an email was sent but it was directed to an international mailbox, and it has not been possible to locate it. We would encourage all UK-based customers to contact Vygon (UK) Ltd directly, and the Technical Department specifically for product enquiries and product complaints (technical@vygon.co.uk).
Whilst the device involved in the incident was not retained for investigation, we are fortunate that the product code and batch number were recorded (code: 00813293, batch: 141019GG). The Vygon (UK) Ltd Service Improvement System (SIS) was reviewed for reports of similar incidents involving product code: 00813293 between 2019 and 2023. We can confirm that we have not received additional reports of a similar nature for product code: 00813293 during this period, having sold approximately 1,156 pieces (2,440 pieces sold worldwide). This is the first time we have become aware of a problem with code 00813293.
We can advise that most guidewires used for placing catheters have a similar design, with an external coil surrounding an internal wire core. The internal core wire gives the necessary rigidity to the guidewire and helps to prevent kinking. The external coil prevents trauma to the patient’s tissues, facilitates negotiation of narrow turns in their anatomy. It also helps prevent loss of the distal section of the wire within the patient should the inner core snap during use. If the external coils are forced to overlap, they can lock in place, and unfortunately, the external wire coil may be vulnerable to stretching if unexpected resistance or tension is encountered.
The Instructions for Use (IFU) provided with the device provide the following recommendations:
“Caution: never pull back or withdraw the guidewire while the needle is in place, this could damage the wire on the needle bevel. If any resistance is felt to the advancement of the guidewire, do not persist, withdraw both the needle and the guidewire simultaneously.
If resistance is felt during guidewire removal, the tip of the guidewire may be kinked within the vessel. Do not persist, but withdraw the catheter relative to the guidewire about 2-3 cm and continue to remove the guidewire. If you still feel resistance withdraw both the catheter and the guidewire simultaneously”
We would like to echo the advice given by Dr Babu that the expiry date of devices should be checked before use and confirm that out-of-date devices should not be used.
We would like to take the opportunity to apologise for any inconvenience caused to Dr Babu and to thank them for bringing this matter to our attention.
