Description of Event or Problem · 0
ON (B)(6) 2026, DURING A LEFT CAROTID ARTERY STENTING (CAS) PROCEDURE PERFORMED VIA RIGHT RADIAL ACCESS, A ZEBRA CATHETER WAS POSITIONED IN THE PROXIMAL COMMON CAROTID ARTERY. DUE TO NEAR-COMPLETE OCCLUSION OF THE LEFT INTERNAL CAROTID ARTERY, MULTIPLE ATTEMPTS WERE MADE TO ADVANCE ANCILLARY DEVICES. DURING ONE ATTEMPT, CONTRAST LEAKAGE WAS VISUALIZED FLUOROSCOPICALLY FROM THE CATHETER AT THE CURVE OF THE BRACHIOCEPHALIC ARTERY. THE CATHETER REMAINED IN POSITION TO PROVIDE SUPPORT AND WAS WITHDRAWN FOLLOWING COMPLETION OF THE PROCEDURE. NO FRAGMENTS WERE RETAINED, AND NO PATIENT INJURY OR ADVERSE CLINICAL OUTCOME WAS REPORTED. EVALUATION OF THE RETURNED DEVICE CONFIRMED A CATHETER SHAFT BREACH APPROXIMATELY 19 CM FROM THE DISTAL TIP (77 CM FROM THE HUB), AS EVIDENCED BY FLUID LEAKAGE DURING FLUSHING. THE DEVICE WAS RETURNED IN ONE PIECE. MICROSCOPIC AND VISUAL INSPECTION OF THE FRACTURE REGION DEMONSTRATED UNIFORM REINFORCEMENT CUT SPACING WITH NO ABNORMAL PITCH VARIATION OR REINFORCEMENT STRUT FRACTURE. THE DAMAGE PATTERN WAS CHARACTERIZED BY LOCALIZED MECHANICAL STRAIN BETWEEN REINFORCEMENT CUTS, RESULTING IN SHEARING OF THE OUTER POLYMER JACKET AND A SLIGHT OPENING OF THE INTERNAL PTFE LINER. NO EVIDENCE OF MATERIAL DEFECT, IMPROPER LAMINATION, ABNORMAL FEED GAP, EXPOSED REINFORCEMENT, STRUCTURAL ANOMALY, OR OTHER MANUFACTURING NONCONFORMANCE WAS IDENTIFIED.