Description of Event or Problem · 0
ON (B)(6), 2026, Q'APEL MEDICAL BECAME AWARE OF A REPORTED ZEBRA 6F 95 CM BERNSTEIN CATHETER FRACTURE THAT OCCURRED DURING A PIPELINE EMBOLIZATION PROCEDURE. THE DEVICE WAS INTRODUCED VIA A MERIT 22 CM 7F SHEATH AND ADVANCED TO THE HIGH PETROUS CAROTID THROUGH TORTUOUS ANATOMY, INCLUDING A 360-DEGREE CERVICAL CAROTID LOOP. THE CATHETER WAS INSPECTED PRIOR TO USE AND NO DEFECTS WERE OBSERVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED PATIENT INJURY. DURING WITHDRAWAL OF THE ZEBRA CATHETER THROUGH THE STATIONARY SHEATH, WHICH WAS NOT RETRACTED, RESISTANCE WAS ENCOUNTERED IN THE CERVICAL CAROTID REGION. THE PHYSICIAN REPORTED THAT THE CATHETER WAS NOT ROTATED, NO VASOSPASM OCCURRED, AND NO EXCESSIVE FORWARD PRESSURE WAS APPLIED. THE PHYSICIAN INDICATED THE MALFUNCTION LIKELY OCCURRED DURING WITHDRAWAL. FOLLOWING REMOVAL, A KINK WAS OBSERVED AND FLUID LEAKAGE WAS NOTED AT THE KINK SITE. NO MULTIPLE REPOSITIONING ATTEMPTS WERE REQUIRED, AND NO TIP MODIFICATION WAS PERFORMED. THE DEVICE WAS REMOVED FROM THE PATIENT AND NO ADDITIONAL INTERVENTION WAS REQUIRED. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION ON (B)(6), 2026. RETURNED PRODUCT ANALYSIS CONFIRMED A CATHETER FRACTURE WITH LUMEN BREACH APPROXIMATELY 7 CM FROM THE DISTAL TIP, CORRELATING WITH THE REPORTED DISTAL KINK LOCATION AND CONSISTENT WITH THE REGION SUBJECTED TO RESISTANCE DURING WITHDRAWAL THROUGH TORTUOUS CERVICAL CAROTID ANATOMY. FLUSHING CONFIRMED FLUID LEAKAGE AT THE FRACTURE LOCATION. MICROSCOPIC AND VISUAL INSPECTION OF THE FRACTURE REGION DEMONSTRATED UNIFORM REINFORCEMENT CUT SPACING WITH NO ABNORMAL PITCH VARIATION, NO REINFORCEMENT STRUT FRACTURE, AND NO EVIDENCE OF MATERIAL OR MANUFACTURING NONCONFORMANCE. THE DISTAL TIP, INCLUDING THE FIRST CENTIMETER FROM THE TIP, SHOWED NO ABNORMALITIES. OVERALL DEVICE LENGTH WAS CONSISTENT WITH PRODUCT SPECIFICATION. ADDITIONAL SHAFT DAMAGE AND MINOR OVALIZATION WERE OBSERVED AT LOCATIONS NOT REPORTED DURING THE CLINICAL EVENT AND AWAY FROM THE PRIMARY FRACTURE SITE. THESE OBSERVATIONS ARE INCONSISTENT WITH THE REPORTED IN-PROCEDURE MALFUNCTION AND ARE MOST CONSISTENT WITH POST-PROCEDURE HANDLING AND RETURN PACKAGING.