ZEBRA

Description of Event or Problem

ON JANUARY 27, 2026, Q'APEL MEDICAL BECAME AWARE OF AN EVENT INVOLVING A ZEBRA 7F 95 CM BERNSTEIN CATHETER DURING AN ANEURYSM EMBOLIZATION PROCEDURE PERFORMED VIA RADIAL ACCESS. AFTER SELECTING THE RIGHT INTERNAL CAROTID ARTERY AND REMOVING A 5F SIM2 COOK CATHETER, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING A VECTA 46, V17, AND SYNCHRO THROUGH THE ZEBRA CATHETER. A 0.035" GLIDEWIRE WOULD NOT PASS. A FRACTURE WAS OBSERVED IN VIVO AT APPROXIMATELY THE DISTAL ONE-THIRD OF THE CATHETER. THE DEVICE WAS GENTLY WITHDRAWN AND REMAINED INTACT DURING REMOVAL; HOWEVER, COMPLETE SEPARATION OCCURRED AFTER EXITING THE SHEATH. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE CATHETER. NO DEVICE FRAGMENTS WERE RETAINED IN THE PATIENT. NO VESSEL INJURY, DISSECTION, PERFORATION, EMBOLIZATION, VASOSPASM, ADDITIONAL INTERVENTION, OR ADVERSE CLINICAL OUTCOME WAS REPORTED. THE PATIENT OUTCOME WAS STABLE. RETURNED PRODUCT EVALUATION CONFIRMED A CATHETER SHAFT SEPARATION LOCATED APPROXIMATELY 19-20 CM FROM THE DISTAL TIP AT THE JACKET TRANSITION REGION. MICROSCOPIC EXAMINATION DEMONSTRATED SEPARATION OF THE LASER CUT TUBE (LCT) WITH INWARD COLLAPSE TOWARD THE LUMEN AND ASSOCIATED POLYMER DISRUPTION. THE FRACTURE MORPHOLOGY WAS CONSISTENT WITH LOCALIZED BENDING AND TENSILE LOADING. NO EVIDENCE OF MATERIAL DEFECT, MANUFACTURING NONCONFORMANCE, OR DESIGN ANOMALY WAS IDENTIFIED.