The customer reported that following a cardiac catheterization procedure in 2001, a vasoseal vhd was deployed. Following deployment, the patient complained of pain, and drainage was noted at the puncture site. A tissue sample was taken and sent to the lab for analysis. The pathology report diagnosis stated "fibroadipose tissue with inflammation and fibrosis consistent with reactive process. " it was noted that the findings may be indicative of an allergic component to the reactive process. No further complications were reported.

Based on co's commercial experience, although co has received reports of allergic reaction following vasoseal deployment, the frequency of reported allergic reactions is extremely low. While allergic reactions to vasoseal collagen are not expected, some patients may experience a foreign body response, which may cause symptoms such as localized inflammation and edema. In addition, the degree of the response is very much patient dependent and therefore, the severity of symptoms will vary from patient to patient. The instructions for use states that since the vasoseal vhd is a collagen product; allergic reaction, foreign body reaction, inflammation, and edema are some of the potential adverse reactions associated with the use of collagen hemostats that should be considered.