FDA Warns Intravascular Device Coatings May Peel

Megan Brooks


November 23, 2015

Hydrophilic and/or hydrophobic coatings on intravascular medical devices may come off, potentially causing serious injuries to patients, the US Food and Drug Administration (FDA) warned today in a safety communication.

Several factors may cause the lubricious coatings to separate from these devices, including difficulty of the procedure and the patient's anatomy, user's technique or using the wrong device for the procedure, improper preconditioning of the device and improper storage conditions, and issues with device design or manufacturing processes, the FDA noted.

Since the beginning of 2010, 11 recalls from various manufacturers have been associated with these coatings peeling or flaking off intravascular medical devices. Most of these recalls were associated with guidewires, but other types of devices have been recalled, including sheaths, retrieval devices, and embolization device delivery wires used in the vasculature, according to the FDA.

Since the beginning of 2014, the FDA has received about 500 Medical Device Reports 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. Most reports involved vascular guidewires, and over three quarters described device malfunctions.

Benefits Continue to Outweigh Risks

Serious adverse events cited in the reports 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 include the persistence of coating fragments in patients, necessitating surgical intervention; adverse tissue reactions; and thrombosis.

The FDA said no specific manufacturer or brand of these devices is associated with higher risks than others. The cause of coating separation is multifactorial and can be associated with factors including device design, device manufacturing, and use. The FDA said use-related issues may be mitigated through proper device selection, preparation, and other considerations.

On the basis of current information, the FDA believes the overall benefits of these devices continue to outweigh the risks. However, they want health providers to consider the following information and actions to reduce the potential of serious adverse events:

  • Be aware that many devices are designed, labeled, and indicated for specific uses. For example, the coating and performance of a device meant to be used in the peripheral vasculature may be different than those of a device meant to be used in the cerebral vasculature.

  • Follow manufacturer's instructions for proper device storage (eg, shelf life, temperature, exposure to light) because improper storage can affect the integrity of the coating.

  • When using two devices together, such as catheter and introducer sheath, ensure there is sufficient room for one to pass safely within the other, considering the features of the device and that some coatings may swell during use. For example, consider using a slightly larger French size for the introducer sheath than the catheter so there is sufficient room between the devices. Review the device labeling or consult the device manufacturer for further information.

  • Follow the manufacturer's recommended preconditioning steps (if applicable) for the device. Preconditioning activates the lubricious properties of some device coatings for optimal use.

  • During preconditioning of the coating, use only the recommended solution; solutions may not be interchangeable and may affect the hydrophilic and/or hydrophobic coatings differently.

  • Avoid using alcohol, antiseptic solutions, or other solvents to pretreat the device because this may cause unpredictable changes in the coating that could affect the device safety and performance. Avoid presoaking devices for longer than instructed because this may affect the coating performance. Avoid wiping the device with dry gauze because this may damage the device coating.

  • Use caution when manipulating, advancing, and/or withdrawing these devices through needles, metal cannulas, stents, or other devices with sharp edges, or through tortuous or calcified blood vessels. Manipulation, advancement, or withdrawal past sharp or beveled edges may result in destruction and/or separation of the outer coating, which may lead to clinical adverse events.

  • Be aware that attempting to alter the shape of devices by bending, twisting, or similar methods may compromise the coating integrity and that damage to the coating may not always be noticeable to the naked eye.

  • Consider replacing a device if it does not move freely, is visibly kinked or otherwise damaged, or does not perform as expected.

  • For further information on how to use a device safely, consult the labeling or contact the device manufacturer.

The FDA encourages health providers to promptly report adverse events with these devices, including coating separating, to MedWatch, the FDA safety information and adverse event reporting program.


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