The FDA recently identified and released a safety communication to health care providers who treat patients for intravascular procedures. The devices in question are used in these minimally invasive vascular procedures:
These types of devices have special lubricated coatings, hydrophilic and hydrophobic, to reduce the friction between the patient’s blood vessels and the devices; giving doctors better precision and reduce injuries to patients.
Unfortunately, these coatings can separate from the devices and cause serious injury to patients. The agency did not identify a particular brand or manufacturer and noted it is still unclear exactly what—design, manufacturing, or improper use—causes the coating to separate from the devices.
In the last year alone, there have been at least 500 reports made to the FDA regarding coating separation.These type of malfunctions can cause injuries such as:
Since 2010 there have been 11 recalls from manufacturers on devices due to coatings separating from devices.
As a patient, be aware of improper preconditioning of the device and improper storage conditions as well as issues with device design or manufacturing processes. Bending or reshaping of the device can increase the risk of the coating to separate as well. If you or someone you know has been injured from these coatings on intravascular medical devices contact (203) 332-7700.