Intravascular Medical Devices: Lubricious Coating Separation

OMEDtechNews & Events

For over 20 years lubricious coatings have offered patients the opportunity to have Announcementless invasive procedures.  Medical devices used during procedures in the cerebrovascular, cardiovascular, and peripheral vascular systems often have hydrophilic and/or hydrophobic lubricious coatings to reduce friction, which creates better maneuverability and less trauma to the blood vessels.  Although the coating is very beneficial the FDA wants health care providers to be aware of the fact that if proper precautions are not taken the coating may come off of the medical devices and cause harm to patients.  Serious adverse injuries and reactions include “pulmonary embolism, pulmonary infarction, myocardial embolism, myocardial infarction, embolic stroke, tissue necrosis, persistence of coating fragments in patients, adverse tissue reactions, thrombosis, and death.” (FDA)

Some tips to avoid coating separation:

  • Use the device properly according to design and label indications
  • Follow proper device storage
  • Ensure there is sufficient room when using two devices together
  • Follow any recommended preconditioning steps
  • Be cautious when moving the device through other devices with sharp edges
  • Avoid trying to alter the shape of the device
  • Replace a device is it appears damaged or does not work properly

For more information about lubricous coating separation see the FDA safety communication.