Description of Event or Problem · 0
ON JANUARY 15, 2026, Q'APEL MEDICAL BECAME AWARE OF AN EVENT INVOLVING A ZEBRA CATHETER. DURING A RADIAL MMA EMBOLIZATION PROCEDURE, THE USER OBSERVED A KINK NEAR THE HUB TOWARD THE END OF THE CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED PATIENT INJURY, AND THE DEVICE WAS REMOVED AND SET ASIDE FOR RETURN EVALUATION. THE USER REPORTED THAT NO ADDITIONAL CATHETERS WERE REQUIRED AND NO ADDITIONAL INTERVENTION WAS NECESSARY. FOLLOWING RETURNED PRODUCT EVALUATION, THE PHYSICIAN CONFIRMED THAT SALINE LEAKAGE WAS OBSERVED FROM THE KINK LOCATION DURING USE; HOWEVER, THE USER REPORTED THAT THE LEAKAGE DID NOT IMPACT THE PROCEDURE OUTCOME AND NO ADDITIONAL INTERVENTION WAS REQUIRED. EVALUATION OF THE RETURNED DEVICE CONFIRMED A CATHETER WALL BREACH/FRACTURE LOCATED APPROXIMATELY 1 CM DISTAL TO THE STRAIN RELIEF, AS EVIDENCED BY FLUID LEAKAGE DURING FLUSHING. VISUAL INSPECTION CONFIRMED A LOCALIZED KINK IN THE PROXIMAL SHAFT REGION NEAR THE HUB/STRAIN RELIEF, CONSISTENT WITH THE REPORTED COMPLAINT. ADDITIONAL KINKS WERE ALSO OBSERVED APPROXIMATELY 14-16 CM PROXIMAL TO THE DISTAL TIP. MICROSCOPIC AND VISUAL INSPECTION OF THE DAMAGED REGION IDENTIFIED NO ABNORMAL COIL SPACING/PITCH VARIATION, AND THE DISTAL TIP SHOWED NO ABNORMALITIES. THE OBSERVED DAMAGE PATTERN WAS CONSISTENT WITH LOCALIZED MECHANICAL DEFORMATION/STRETCHING. NO VISUAL EVIDENCE OF A DESIGN ANOMALY OR MANUFACTURING DEFECT WAS OBSERVED DURING THE RETURNED PRODUCT EVALUATION.