JETSTREAM? XC

Description of Event or Problem

IT WAS REPORTED THAT GUIDEWIRE ENTRAPMENT OCCURRED. A 2.1MM JETSTREAM? XC ATHERECTOMY CATHETER WAS SELECTED FOR USE IN A RIGHT LEG SUPERFICIAL FEMORAL ARTERY ATHERECTOMY AND STENTING PROCEDURE. THIS DEVICE WAS ADVANCED OVER A 300CM, 0.014IN NON-BOSTON SCIENTIFIC GUIDEWIRE. AFTER THE FIRST PASS WHEN TRYING TO RETRACT THE DEVICE IN REX MODE, IT BECAME STUCK ON THE GUIDEWIRE, AND THE ENTIRE SYSTEM HAD TO BE REMOVED. GUIDEWIRE ACCESS WAS LOST. AFTER REGAINING GUIDEWIRE ACCESS, THE PROCEDURE WAS ABLE TO BE COMPLETED. THE PROCEDURE WAS PROLONGED, BUT THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

INVESTIGATION RESULTS: DEVICE ANALYSIS FINDINGS: THE RETURNED PRODUCT CONSISTED OF A JETSTREAM ATHERECTOMY CATHETER WITH AN UNKNOWN 0.014IN GUIDEWIRE STILL INSIDE THE DEVICE. VISUAL AND MICROSCOPIC INSPECTION REVEALED NO DAMAGES. THE UNKNOWN GUIDEWIRE WAS ABLE TO BE REMOVED WITHOUT ANY ISSUES. A TEST GUIDEWIRE WAS INSERTED INTO THE DEVICE AND WAS ABLE TO PASS THROUGH WITHOUT ANY ISSUES. DEVICE HISTORY RECORD REVIEW: IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW: REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THERE WAS RELEVANT CONTENT AND SUFFICIENT GUIDANCE WITH RESPECT TO THE CIRCUMSTANCES DESCRIBED WITHIN THIS COMPLAINT. NO UPDATES ARE REQUIRED TO THE IFU AS A RESULT OF THIS EVENT. INVESTIGATION CONCLUSION: BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF NO PROBLEM DETECTED.