Intravascular Medical Devices: FDA Safety Communication - Lubricious Coating Separation
Including medical devices such as intravascular catheters, guidewires, balloon angioplasty catheters, delivery sheaths, and implant delivery systems
The Food and Drug Administration (FDA) wants to make health care providers aware of the possibility that hydrophilic and/or hydrophobic coatings may separate (e.g., peel, flake, shed, delaminate, slough off) from medical devices and potentially cause serious injuries to patients. Coating separation can be caused by a number of factors, ranging from the difficulty of the procedure and the patient’s anatomy to practitioner technique or using the wrong device for the procedure, to improper preconditioning of the device and improper storage conditions as well as issues with device design or manufacturing processes. Based on current information, the FDA believes the overall benefits of these devices continue to outweigh the risks. However, health care providers should be aware of potential problems and consider certain actions prior to use.
Since Jan. 1, 2010, there have been 11 recalls from various manufacturers associated with these coatings peeling or flaking off of medical devices. The majority of the recalls were associated with guidewires, but there have also been recalls for other types of devices including sheaths, retrieval devices and embolization device delivery wires used in the vasculature.
In addition, since Jan. 1, 2014, the FDA has received approximately 500 Medical Device Reports (MDRs) describing separation of hydrophilic and/or hydrophobic coatings on medical devices such as guidewires, catheters, and introducers that had been used for cerebrovascular, cardiovascular and peripheral vascular procedures. The majority of the reports were submitted for vascular guidewires and over 75% of the reports describe device malfunctions.
Serious adverse events reported in these MDRs and in the scientific literature include pulmonary embolism, pulmonary infarction, myocardial embolism, myocardial infarction, embolic stroke, tissue necrosis, and death. Serious injuries associated with the peeling of coatings reported in MDRs included the persistence of coating fragments in patients, requiring surgical intervention to mitigate the consequences, adverse tissue reactions, and thrombosis.
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