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Patient 1
THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE SUBJECT DEVICE WAS RETURNED IN TWO SEGMENTS. THE MICROCATHETER AND GUIDEWIRE USED WITH THE BALLOON CATHETER WERE NOT RETURNED. THE BALLOON WAS SEPARATED AT APPROXIMATELY 113.5CM FROM ITS PROXIMAL AND WAS SEVERELY STRETCHED AND SEPARATED ON ITS MIDDLE SHAFT. THE CORE WIRE WAS PROTRUDING THROUGH THE BALLOON PROXIMAL SIDE SEPARATED END. THE BALLOON MIDDLE SHAFT WAS SEVERELY KINKED, COMPRESSED AND WRINKLED ON SEVERAL PLACES ALONG ITS LENGTH. THE DISTAL SHAFT WAS SEVERELY KINKED, STRETCHED, COMPRESSED AND WRINKLED ON SEVERAL PLACES ALONG ITS LENGTH. THE DISTAL SHAFT WAS WRINKLED IN THE BALLOON SECTION AS WELL. THE PROXIMAL SHAFT WAS BENT AT 3.0CM AND 101.0CM FROM ITS PROXIMAL. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE DAMAGED CONDITION OF THE RETURNED CATHETER. INFORMATION AVAILABLE INDICATED THAT THE DEVICE WAS CONFIRMED TO BE IN GOOD CONDITION PRIOR TO USE, CONTINUOUS FLUSH WAS MAINTAINED, PATIENT HAD A NORMAL ANATOMY AND THE GUIDEWIRE WAS JAMMED INSIDE THE CATHETER. BASED ON THE INFORMATION CURRENTLY AVAILABLE, IT IS PROBABLE THAT SOME PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE LIMITED THE PERFORMANCE OF THE BALLOON CATHETER CONTRIBUTING TO THE REPORTED AND OBSERVED DAMAGES. THEREFORE, AN ASSIGNABLE CAUSE OF OPERATIONAL CONTEXT HAS BEEN ASSIGNED TO THIS INVESTIGATION.