ZEBRA

Description of Event or Problem

ON (B)(6) 2026, DURING A NEUROVASCULAR PROCEDURE PERFORMED VIA FEMORAL ACCESS, A ZEBRA 7F 95 CM CATHETER WAS UTILIZED WITH A CORDIS 5F SIM 125 CM DIAGNOSTIC CATHETER WHILE NAVIGATING TORTUOUS ILIAC ANATOMY AND TRACKING ACROSS THE AORTIC ARCH. DURING USE, RESISTANCE WAS REPORTEDLY ENCOUNTERED AND SALINE LEAKAGE WAS OBSERVED FROM A KINKED REGION OF THE ZEBRA CATHETER APPROXIMATELY 1 INCH DISTAL TO THE STRAIN RELIEF SEGMENT. THE SIM CATHETER WAS SUBSEQUENTLY IDENTIFIED TO BE FRACTURED WITHIN THE ZEBRA CATHETER. THE PROXIMAL PORTION OF THE SIM CATHETER WAS REMOVED, AFTER WHICH THE ZEBRA CATHETER WAS PARTIALLY WITHDRAWN AND CUT TO EXPOSE THE RETAINED SIM CATHETER SEGMENT. THE ZEBRA AND RETAINED SIM CATHETER SEGMENT WERE THEN CLAMPED TOGETHER AND REMOVED SIMULTANEOUSLY FROM THE PATIENT. THE SEPARATED SIM CATHETER SEGMENT REMAINED ACCESSIBLE OUTSIDE THE PATIENT VASCULATURE; REMOVAL WAS COMPLETED WITHOUT INVASIVE RETRIEVAL OR SURGICAL INTERVENTION, NO RETAINED FRAGMENTS REMAINED IN THE PATIENT, AND NO PATIENT INJURY OR MEDICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT WAS REPORTED. THE PHYSICIAN SUBSEQUENTLY CONVERTED TO ANOTHER CATHETER, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. RETURNED PRODUCT EVALUATION CONFIRMED SIGNIFICANT SHAFT DEFORMATION AND A LOCALIZED LUMEN BREACH/KINK NEAR THE PROXIMAL ZEBRA SHAFT, CONSISTENT WITH THE REPORTED LEAKAGE LOCATION. ADDITIONAL SHAFT FLATTENING AND COMPRESSION DAMAGE APPEARED CONSISTENT WITH PHYSICIAN RETRIEVAL MANEUVERS INVOLVING FORCEPS MANIPULATION AND INTENTIONAL CUTTING OF THE CATHETER TO FACILITATE REMOVAL OF THE RETAINED SIM CATHETER SEGMENT. EVALUATION OF THE RETURNED DEVICES IDENTIFIED NO EVIDENCE OF MANUFACTURING NONCONFORMANCE OR MATERIAL ANOMALY