during the procedure. Average number of device issues was also included on the basis of the total number of unique device issues reported per entry. Criteria for determining unique device issued included any reported device or device component malfunction, for example, failure to cycle, material separation, deformation, device component detachment, and activation failure. Analysis was undertaken with Fisher exact and two-tailed t-test.Results: A total of 2930 total reports were examined (1465 reports for each closure device), of which 568 were AS and 431 PP for adverse events. The three categories of complications are compared in Table I; 69.7% (n ¼ 396) PP and 98.8% (n ¼ 426) AS entries stated the access French size (Table II).Conclusions: In patients undergoing transfemoral angiography, there is no statistical difference in the rate of cutdowns over the 6F, 7F, or 8F sheath sizes. It appears that at smaller (6F) sheath size, the AS is more beneficial with equal rates of hematoma formation and decreased requirements of manual compression. At the largest sheath size, we notice that there are statistically fewer hematomas with the PP device, even though there is an increased rate of manual compression for hemostasis.
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