The date recorded in section b3 was provided by the cordis sales rep who stated that the procedure date was sometime in the last week of january - probably the date of 1/27/98. The product labeling states the following: 1. The p3008 is indicated for use in pt's with obstruction of major biliary ducts. 2. Use of an inflation device with a manometer is recommended during this procedure to minimize the risk of overinflation. 3. Recommends a 10f introducer sheath.

Prior to introducing a endovascular stent with delivery system, the pt's vasculature was accessed via cutdown with a 9f introducer sheath rather then through percutaneous puncture. Subsequently, the sds was successfully advanced to the target lesion site in the pt's left common iliac. Upon the initial inflation attempt. It was reported that the balloon catheter only inflated to a 1/2 atm of pressure before losing pressure entirely. In response, a 10cc syringe filled with diluted contrast media for a rapid injection was utilized. As a result, the balloon ruptured instead of inflating resulting in the partial deployment of the stent. To address this occurrence, the delivery balloon and the stent were withdrawn to the distal tip of the introducer sheath. An unsuccessful attempt was made to withdraw the delivery balloon from the sheath and the sheath from the artery. The femoral access site was widened in response by increasing the length of the cut-down and all devices were successfully withdrawn. Another device was used to successfully advance and deploy a stent at the target lesion site. There was no add'l complications reported relative to this event.