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May 8, 2014
2 Min Read
Cook Medical Evolution RL lead extraction system (Courtesy Cook Medical)
Following an FDA Warning Letter citing the firm for failing to update the 510(k) clearance for its Evolution RL and Evolution Shortie RL lead extraction systems, Cook Medical (Bloomington, IN) has pulled the devices from the US market.
The Warning Letter says that Cook was selling "this device with major changes or modifications to the intended use without submitting a new premarket notification to FDA."
The Evolution RL Controlled-Rotation Dilator Sheath Set, which originally received approval in 2006, and the Evolution Shortie RL Controlled-Rotation Dilator Sheath Set are intended for "use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects," according to Cook's website.
Objections detailed by the Warning Letter include that the original, cleared device did not have a birotational sheath that provides a mechanism for changing the rotational direction, or have a decagon-shaped tip. The cleared device only cut tissue when rotating clockwise, whereas the current design cuts in either direction.
"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 Warning Letter continues, "(t)he 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)."
The privately-held Cook has not released a statement responding to the Warning Letter. The company has, however, added the boxed line, "This product is not available in the United States." to the product description pages for the affected devices on its website. Doubtless, fresh paperwork destined for FDA is being churned out with all due haste.
Cook Medical makes 16,000 products that serve 13 hospital lines and provides products to 135 countries.
Stephen Levy is a contributor to Qmed and MPMN.
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