THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE NO PHYSICAL ANALYSIS OF THE DEVICE CAN BE PERFORMED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE MANUFACTURING BATCH RECORDS FOR THE COMPLAINT DEVICE CANNOT BE REVIEWED. AT THIS TIME IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. AS NOTED IN THE PRECAUTIONS WITHIN THE DEVICE INSTRUCTIONS FOR USE, "FREE MOVEMENT OF THE GUIDEWIRE WITHIN A CATHETER IS AN IMPORTANT FEATURE OF THE STEERABLE GUIDEWIRE SYSTEM BECAUSE IT GIVES THE USER VALUABLE TACTILE INFORMATION. TEST THE SYSTEM FOR ANY RESISTANCE PRIOR TO USE." BASED ON THE INFORMATION PROVIDED TO DATE, CLINICAL AND/OR PROCEDURAL FACTORS APPEAR TO HAVE IMPACTED ON THE EVENT AS REPORTED. PATIENT AGE WAS REPORTED TO BE OVER 18 YEARS. IF THERE IS ANY FURTHER RELEVANT INFORMATION PROVIDED, A FOLLOW UP MEDWATCH REPORT WILL BE FILED.
D
Patient 1
EVENT DESCRIPTION: PER EMAIL, IT WAS REPORTED THAT: AFTER DOING TWO PASSES WITH THE BLADES OFF. THEY HAD THE BLADES OFF THEN THEY WERE UNABLE TO RETRACT DUE TO THE WIRE SPINNING WITHIN THE CATHETER. THIS HAPPEN DURING THE CASE. THEY HAD TO PULL THE ENTIRE DEVICE OUT AND THEY DON'T HAVE TO PUT IN ONE IN. NO COMPLICATION AND PATIENT IS FINE. (B)(6) 2020: AS PER ADDITIONAL INFORMATION RECEIVED: WHEN ATTEMPTING TO REX THE JETSTREAM CATHETER OUT, THE DEVICE BECAME STUCK ONTO THE THRUWAY WIRE AND WE WERE UNABLE TO REX OUT. THE WIRE AND JETSTREAM WERE REMOVED TOGETHER AS ONE UNIT.