FDA Warns of Possible Patient Injury if Coating Separates from Intravascular Medical Device

Coating on Medical Devices Can Cause Patient Injuries

Coating on Medical Devices Can Cause Patient Injuries

The Food and Drug Administration (FDA) has issued a safety communication warning of the possibility of patient injury if the hydrophilic and/or hydrophobic coatings on medical devices separate—peel, flake, shed, delaminate, slough off—during use.

A number of factors can cause coating separation, including the difficulty of the procedure and the patient’s anatomy, the practitioner’s technique, and use of the wrong device for the procedure. Improper preconditioning of the device and improper storage can also contribute to the problem, as can issues with the device’s design or the manufacturing process.

Since January 2010, there have been 11 device recalls associated with peeling or flaking coatings. Most of the recalls were associated with guidewires, but there have also been recalls for sheaths, retrieval devices and embolization device delivery wires used in the blood vessels. Since January 2014, the FDA has received approximately 500 Medical Device Reports (MDRs) describing separation of coatings on  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 percent of the reports describe device malfunctions.

Serious adverse events reported include pulmonary embolism, pulmonary infarction (blockage), myocardial embolism, myocardial infarction, embolic stroke, tissue necrosis, and death. Some patients required surgical intervention to retrieve coating fragments and prevent serious consequences.

The FDA believes the overall benefits of the intravascular devices continue to outweigh the risks, but the agency cautions health care providers about potential problems. No specific manufacturer or brand of device is associated with higher risks than others. FDA analysis suggests that use-related issues may be mitigated through proper device selection and preparation.

Health care providers should be aware that many devices are designed, labeled and indicated for specific uses and the right device should be chosen for the procedure.

Improper storage can affect the integrity of a device’s coating so health care facilities should carefully follow the manufacturer’s instructions for proper device storage, including temperature and exposure to light, and shelf life recommendations.

When two devices are used together—a catheter and introducer sheath, for example—the user should ensure there is sufficient room for one to pass safely within the other, taking into consideration the features of the device (e.g., curved tip), and that some coatings may swell during use. Users should follow recommended preconditioning steps (if applicable), to properly activate the slippery properties of a device coating.  Use only the recommended solution because solutions may not be interchangeable and may affect coatings differently. Alcohol, antiseptic solutions, or other solvents may cause unpredictable changes in the coating, which could affect the device safety and performance. Avoid pre-soaking devices for longer than instructed, and do not wipe the device with dry gauze, which may damage the device coating.

To avoid patient injury, health care providers should consider replacing a device if it does not move freely, is visibly kinked or damaged, or does not perform as expected.


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