The customer reported that following a ptca procedure in 2001, a vasoseal es was deployed. A small hematoma was noted post deployment. After returning to the icu, the pt experienced a vasovagal episode and was intermittently unstable. On the same day, a cat scan revealed a right retroperitoneal bleed and a possible pseudoaneurysm in the right femoral artery. On the next day, a sonogram of the bilateral lower extremity revealed deep vein thrombosis of the right femoral artery at the groin, a pseudoaneurysm, and a large amount of retroperitoneal hematoma. The physician reported that approx 36 hours post deployment, the pt was taken to the operating room and was hemodynamically stabilized. No further complications have been reported.

Based on the co's experience, hematomas and pseudoaneurysms can result if the vasoseal collagen is not placed accurately over the arterial puncture site or if it is displaced following the procedure. Retroperitoneal bleeds can result if the initial puncture site is higher than that recommended for use with vasoseal or if a double wall stick occurs. The vasoseal instructions for use states that in order to optimize placement of the vasoseal collagen, the following points should be observed when performing the arterial puncture: the puncture of the common femoral artery should be made 3-4 cm below the inguinal ligament to allow compression of the artery and placement of the sheath without kinking. A single puncture to the anterior, medial aspect of the common femoral artery is recommended. Puncture of the superficial femoral artery should be avoided. In addition, the skin and artery should be punctured at a 45-60 degree angle to allow for placement of catheters and to promote proper placement of the vasoseal collagen in the artery. Based on the co's commercial experience, the frequency of reported hematomas, pseudoaneurysms, and retroperitoneal bleeds is extremely low. Based on the co's experience these complications do not indicate that the device is defective. The risk of hematoma, pseudoaneursym, and retroperitoneal bleed are all recognized as potential complications associated with cardiac catheterization procedures.