ZEBRA

Description of Event or Problem

ON JANUARY 28, 2026, Q'APEL MEDICAL BECAME AWARE OF AN EVENT INVOLVING A 7F 95 CM ZEBRA SIM2 CATHETER DURING A MECHANICAL THROMBECTOMY PROCEDURE PERFORMED VIA RIGHT RADIAL ACCESS FOR TREATMENT OF A RIGHT-SIDED M2 OCCLUSION. FOLLOWING THROMBECTOMY, RESIDUAL STENOSIS WAS NOTED AND THE ZEBRA CATHETER WAS ADVANCED WITH THE INTENT TO POSITION IN THE INTERNAL CAROTID ARTERY (ICA). RESISTANCE WAS ENCOUNTERED AT THE SUBCLAVIAN-CAROTID TAKEOFF DURING ADVANCEMENT. THE CATHETER WAS SUCCESSFULLY POSITIONED IN THE PETROUS ICA. AFTER REMOVAL OF THE SIM2 CONFIGURATION AND RELOADING WITH AN ESPERANCE CATHETER AND CARRIER SYSTEM, THE SYSTEM COULD NOT BE ADVANCED PAST THE SUBCLAVIAN-CAROTID JUNCTION. THE DECISION WAS MADE TO REMOVE THE SYSTEM AND TRANSITION TO AN ALTERNATIVE SUPPORT CATHETER. UPON REMOVAL, THE ZEBRA CATHETER WAS OBSERVED TO HAVE A REDUCED DIAMETER, AND INSPECTION IDENTIFIED A TRANSVERSE FRACTURE APPROXIMATELY ONE-THIRD OF THE CATHETER LENGTH FROM THE PROXIMAL END. IMAGING CONFIRMED CATHETER SEPARATION, WITH THE DISTAL SEGMENT RETAINED IN THE SUBCLAVIAN ARTERY. TWO SNARE DEVICES WERE USED TO RETRIEVE THE RETAINED SEGMENT. RETRIEVAL WAS REPORTED AS SUCCESSFUL WITH NO IMMEDIATE PATIENT COMPLICATION. NO DEVICE FRAGMENTS REMAINED IN THE PATIENT FOLLOWING RETRIEVAL. THE PATIENT OUTCOME WAS REPORTED AS STABLE. IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ADDITIONAL THROMBECTOMY PROCEDURE THE FOLLOWING DAY. THE RELATIONSHIP OF THIS SUBSEQUENT PROCEDURE TO THE REPORTED DEVICE EVENT IS UNKNOWN. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER, AS THE HOSPITAL INITIATED AN INTERNAL REVIEW. AT THE TIME OF THIS REPORT, Q'APEL MEDICAL HAS NOT RECEIVED THE DEVICE FOR EVALUATION.