FDA issues warning for intravascular medical devices

The Food and Drug Administration yesterday issued a safety announcement alerting health care providers to the possibility that the coating on certain intravascular medical devices may separate and cause injury to patients. Devices such as intravascular catheters, guidewires, balloon angioplasty catheters, delivery sheaths and implant delivery systems often have hydrophilic and/or hydrophobic lubricious coatings to reduced friction with blood vessels. According to FDA, separation of the coating can occur for a number of reasons ranging from the difficulty of the procedure to device design and manufacturing. Serious injuries reported include the persistence of coating fragments in patients, requiring surgical intervention to mitigate the consequences, adverse tissue reactions and thrombosis. “Based on current information, the FDA believes the overall benefits of these devices continue to outweigh the risks,” the announcement states. “However, health care providers should be aware of potential problems and consider certain actions prior to use.” The safety communication lists information and actions providers may take in order to reduce the potential of serious adverse events. FDA has not concluded that any specific manufacturer or brand is associated with higher risks. For more, see the safety announcement.