ZEBRA

Description of Event or Problem

DURING AN MMA EMBOLIZATION PROCEDURE PERFORMED VIA FEMORAL ACCESS ON (B)(6) 2026, RESISTANCE WAS REPORTEDLY ENCOUNTERED BY THE PHYSICIAN DURING WITHDRAWAL OF A ZEBRA 6F 95 CM CATHETER WITHIN TORTUOUS ILIAC ANATOMY. THE PHYSICIAN REPORTED ASSOCIATED VESSEL SPASM, AFTER WHICH THE CATHETER REPORTEDLY KINKED, TWISTED, AND SEPARATED DURING REMOVAL ATTEMPTS. THE SEPARATED CATHETER SEGMENTS WERE REPORTEDLY RETRIEVED USING A SNARE, AND NO FRAGMENTS WERE REPORTED TO REMAIN IN THE PATIENT. THE PATIENT WAS REPORTED TO BE STABLE FOLLOWING RETRIEVAL OF THE CATHETER SEGMENTS. THE PRODUCT WAS RETURNED IN FOUR SHAFT SEGMENTS. EVALUATION IDENTIFIED MULTIPLE FRACTURE/SEPARATION LOCATIONS. THE COMBINED SEGMENT LENGTHS WERE CONSISTENT WITH THE MANUFACTURED DEVICE LENGTH SPECIFICATION, AND NO SIGNIFICANT ELONGATION WAS IDENTIFIED. VISUAL AND MICROSCOPIC EVALUATION IDENTIFIED TWISTING, FLATTENING, PINCHING, AND LOCALIZED COMPRESSION DAMAGE ACROSS MULTIPLE REGIONS OF THE CATHETER. THE FRACTURE MORPHOLOGY APPEARED TORN AND IRREGULAR, CONSISTENT WITH MECHANICAL STRESS DURING DEVICE REMOVAL AND RETRIEVAL. FEED GAP SPACING AND REINFORCEMENT PATTERN WERE OBSERVED TO BE UNIFORM THROUGHOUT THE EVALUATED REGIONS. NO EVIDENCE OF ABNORMAL REINFORCEMENT SPACING, STRUCTURAL ANOMALIES, OR OTHER MANUFACTURING-RELATED NONCONFORMANCE WAS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT IS MOST CONSISTENT WITH MECHANICAL OVERSTRESS DURING WITHDRAWAL THROUGH TORTUOUS ANATOMY WITH RESISTANCE ENCOUNTERED DURING REMOVAL.