GATEWAY OTW 1.5MM X 9MM - CE

Description of Event or Problem

IT WAS REPORTED THAT IN A SURGICAL PROCEDURE FOR STENOSIS OF THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY, THE PHYSICIAN INTENDED TO PERFORM PTA (PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY) USING BALLOON DILATION. AFTER ESTABLISHING THE VASCULAR ACCESS SYSTEM, THE PHYSICIAN SELECTED THE SUBJECT BALLOON DEVICE, FLUSHED IT THOROUGHLY, AND GUIDED IT TO THE LESION SITE VIA A GUIDEWIRE. SUBSEQUENTLY, THE PHYSICIAN USED A PRESSURE PUMP TO INFLATE THE SUBJECT BALLOON TO ITS RATED PRESSURE. HOWEVER, UNDER IMAGING GUIDANCE, IT WAS OBSERVED THAT THE SUBJECT BALLOON FAILED TO OPEN ON THE FIRST ATTEMPT, AND REPEATED ATTEMPTS ALSO PROVED UNSUCCESSFUL. THE PHYSICIAN THEN WITHDREW THE SUBJECT BALLOON FROM THE BODY AND, UPON INFLATING IT EXTERNALLY, DISCOVERED THAT THE SUBJECT BALLOON HAD RUPTURED. A REPLACEMENT SUBJECT BALLOON WAS THEN USED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.