The eval of the event is based on mfg and qc procedures, and history of device related to this event. The returned sample was evaluated by engineering department. All returned components conform to specification. The inspection showed that the sheath and hub were separated. The sheath was distorted in a serpentine fashion, and a kink was located approximately. 800" from the distal end. The collagen plug was trapped above the kink, and lodged between the kink and the proximal end of the sheath. The sheath was bent at an angle of approximately 90 degrees (toward the proximal end). It appears that the bend may have been caused by a surgical tool used to extract the sheath from the puncture site. It is probable that the kink in the sheath developed as result of occlusive force applied perpendicular (i. E. , normal) to the sheath. A kinked sheath inhibits the collagen path, transferring force from the plunger to the sheath tube, resulting in a separation of the sheath from its hub. During use of vasoseal vhd, steady occlusive pressure must be maintained above the puncture site. The customer will be advised of findings and referred to the entire procedure as outlined in the vasoseal vhd instructions for use supplied with the product.

The customer reported that following a diagnostic catheterization procedure on may 17, 1999, a size 6 vasoseal vhd collagen plug was deployed in the patient. During deployment of a second collagen plug, the sheath separated from its hub and the vasoseal vhd sheath remained in the patient's groin. The sheath was removed from the patient's groin with hemostats under fluoroscopy. No further complications were reported.