Field Safety Notice Philips Visions PV.014P, PV.014P RX and PV.018 Digital IVUS Catheters Instructions for Use (IFU) Precaution Update (ICN 3008)

NHSSC: 45

Alert:

• Philips has issued a Field Safety Notice to advise of an update to the Instructions for Use (IFU), for Visions PV.014P, PV.014P RX and PV.018 Digital IVUS Catheters.
• A new precaution will be added to the Instructions for Use:
  • Use a guide sheath of appropriate length to provide adequate support to the rapid exchange IVUS catheter and guidewire.
• Philips has been informed of cases where physicians, during “radial-to-peripheral” procedures (radial access), have used a Digital IVUS Catheter without the appropriate sheath and/or guide catheter; this inappropriate use could lead to failure to provide adequate support for manoeuvring the guidewire and catheter to peripheral vessels.
• Philips advise when using a short radial artery sheath with a Visions PV.014P Digital IVUS Catheter over an .014 guide wire, for example, the user may experience resistance while loading and removing the catheter. If the user removes the wire and catheter together without forcing, there should be no expected harm to the patient.
• However, if the user continues the procedure despite resistance, the catheter and guide wire could get tangled, potentially requiring further intervention. In some cases, longer sheaths can assist, but surgical removal may be necessary.
• Philips confirm there have been seven adverse events requiring additional intervention, no deaths have been reported for this issue.

Products Affected:

• One of the products affected is available via NHS Supply Chain:

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected pr
• Philips also recommend customers post this Field Safety Notice on or near the affected products until they have updated the Instruction for Use.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Hospital Care team.

Please be aware that in the event of a Field Safety Notice/Product Recall we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.