Description of Event or Problem · 0
ON (B)(6) 2025, DURING A RIGHT RADIAL ACCESS TO RIGHT CAROTID ARTERY STENTING PROCEDURE, SEQUENTIAL PRE-DILATION WAS PERFORMED USING A 5F SHORT SHEATH FOLLOWED BY A 6F SHORT SHEATH. A 7F ZEBRA SIM2 CATHETER WAS THEN INTRODUCED WITHOUT THE USE OF AN INTRODUCER SHEATH. A SPIDER FILTER WAS ADVANCED AND POSITIONED JUST BEYOND THE FIRST BEND IN THE PETROUS SEGMENT. A CONTEGO CAROTID STENT WAS SUCCESSFULLY DELIVERED AND DEPLOYED WITH SUPPORT FROM THE ZEBRA CATHETER. DURING RETRIEVAL OF THE STENT AND SPIDER FILTER SYSTEM, DIFFICULTY WAS ENCOUNTERED WHEN THE FILTER WIRE APPEARED TO KINK, PREVENTING PROPER CAPTURE WITHIN THE RETRIEVAL SHEATH. THE DAMAGED WIRE WAS SUBSEQUENTLY PULLED THROUGH THE DEPLOYED STENT, AND RESISTANCE WAS NOTED WHEN ALL COMPONENTS WERE WITHDRAWN THROUGH THE ZEBRA CATHETER. A CONTRAST RUN WAS THEN PERFORMED TO CONFIRM PROCEDURE COMPLETION. UPON SUBSEQUENT REMOVAL OF THE ZEBRA CATHETER, ADDITIONAL RESISTANCE WAS ENCOUNTERED, AND A SEPARATION OF THE CATHETER OCCURRED OUTSIDE OF THE PATIENT. THE CATHETER WAS SUCCESSFULLY REMOVED IN IT'S ENTIRETY. THERE WAS NO ADVERSE IMPACT TO THE DEPLOYED STENT, AND NO PATIENT HARM OR CLINICAL COMPLICATIONS WERE REPORTED. AT THE TIME OF THIS INITIAL REPORT, THE DEVICE HAD NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF THE DEVICE IS RETURNED AND FURTHER INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE ISSUED. BASED ON THE COMPLAINT DETAILS AND PROCEDURAL CONTEXT, THE FAILURE IS MOST CONSISTENT WITH USE-RELATED FACTORS-SPECIFICALLY, EXCESSIVE MECHANICAL FORCE DURING ADVANCEMENT AGAINST RESISTANCE-RATHER THAN A DEVICE DEFECT. THIS IS CONSISTENT WITH THE ZEBRA CATHETER'S INSTRUCTIONS FOR USE (IFU), WHICH CAUTION THAT MANIPULATION AGAINST RESISTANCE MAY RESULT IN DAMAGE TO THE VESSEL OR THE DEVICE