Inspections, Compliance, Enforcement, and Criminal Investigations
Cook Vascular Inc. 4/15/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Avenue|
Silver Spring, MD 20993
APR 15, 2014
Jim Ferguson, Jr.
Quality System Manager
Cook Vascular, Inc.
1186 Montgomery Lane
Vandergrift, Pennsylvania 15690-6065
Re: Cook Evolution RL Bi-directional Dilator Sheath Sets
Refer to CMS #418168
Dear Mr. Ferguson:
The United States Food and Drug Administration (FDA) has learned that your firm is marketing the Cook Evolution RL and the Shortie RL Bi-directional Dilator Sheath Sets in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
Under section 201(h) of the Act, 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
The FDA has reviewed your firm’s website at http://cookmedical.com and determined that the Cook Evolution RL and the Shortie RL Bi-directional Dilator Sheath Sets are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the devices as described and marketed. The devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution this device with major changes or modifications to the intended use without submitting a new premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(ii).
Specifically, the Cook Evolution Mechanical Dilator Sheath Set was cleared under K061000 for use in the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters, and foreign objects. However, review of your firm’s promotional material provides evidence that the device has undergone design changes including what appears to be an extension to the Evolution line and material changes to the sheath since the device was cleared. As described in the promotional materials on your firm’s website and in a product brochure, these changes represent major changes or modifications to the intended use of your firm’s device. These changes include but are not limited to:
A brochure for the Evolution RL lead extraction system that includes the Evolution Shortie RL: “Evolve your Lead Extraction™ procedures with controlled bidirectional rotation.” The brochure provides the following information about the device:
o “Birotational Sheath
o Rotate in alternating directions or continuously in either direction
o Rotate fully or partially, depending on the length of the trigger pull
o Decagon Shaped Tip
o Avoids tissue wrap and deflects companion leads
o Maintains forward progression whether it rotates right or left : Responsive, Contoured Handle
o Intuitive two-stage trigger changes the direction of rotation without buttons or switches
o Evolution Shortie RL
o Designed specifically for vessel entry”
The cleared birotational sheath does not provide a mechanism for changing the rotational direction or have a decagon-shaped tip. It only cuts tissue when rotating clockwise. We also note that your firm has updated the handling system and is offering larger-sized sheaths than what is described for the original cleared system, which had inner sheath IDs of 7.0 and 9.0 FR. The new devices include sheath sizes of 11.0 and 13.0 FR. A larger size for this sheath may incur new risk factors, which would need to be evaluated and mitigated. In addition, your firm is offering what appears to be a new device system, the Evolution Shortie RL Dilator Sheath Set, which claims to be designed specifically for vessel entry. These claims will need to be substantiated and evaluated in a new 510(k).
For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency, 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
Our office requests that Cook Vascular immediately cease activities that result in the misbranding or adulteration of the Cook Evolution Mechanical Dilator Sheath Set, such as the commercial distribution of the devices for the uses discussed above.
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Your firm’s response should be sent to:
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
Field Inspections Support Branch
White Oak Building 66, Rm 2609
10903 New Hampshire Ave.
Silver Spring, MD 20993
Refer to the identification number CMS #418168 when replying. We remind you that only written communication is considered as official. If you have any questions about the contents of this letter, please contact: LaShanda Long, Chief, Surveillance and Enforcement Branch I, Division of Premarket and Labeling Compliance, at (301) 796-5465.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm. It is your firm’s responsibility to ensure compliance with the applicable laws and regulations administered by FDA.
Steven D. Silverman
Office of Compliance
Center for Devices and