Zellner C, Ports TA, Yeghiazarians Y,

Abstract

Trans-radial cardiac catheterization has lower rates of arterial access site complications. Hydrophilic-coated sheaths designed specifically for trans-radial procedures have resulted in numerous reports of a foreign body reaction to retained material. Although this is a self-limited condition that should be managed expectantly, it is often confused with an infected pseudoaneurysm, resulting in unnecessary surgery. We searched the FDA MAUDE (Manufacturer and User Facility Device Experience) database to determine which brands of sheath have been associated with this complication. In addition, we performed a literature search for all reported cases of this complication. Only one brand of sheath has been associated with this condition. As trans-radial procedures become more common in the US, knowledge of such complications, which appear to be specific to the Cook radial hydrophilic-coated sheaths, is imperative for all radial interventionalists to prevent unnecessary surgical procedures.

Catheter Cardiovasc Interv. 2010 Nov 1;76(5):673-6.