Description of Event or Problem · 0
ON (B)(6) 2025, DURING A RIGHT RADIAL ACCESS TO LEFT CAROTID ARTERY STENTING PROCEDURE, THE PHYSICIAN USED A 6F SHEATH AND A SELECT CATHETER TO ACCESS THE CAROTID ARTERY. AFTER SUCCESSFUL DILATION, THE PHYSICIAN EXCHANGED THE SYSTEM FOR A 7F ZEBRA CATHETER, REMOVING THE 6F SHEATH. THE CAROTID STENT WAS SUCCESSFULLY PLACED. UPON REMOVAL OF THE 7F ZEBRA CATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AT THE RADIAL ARTERY, NOTING A LIKELY VASOSPASM. UPON CONTINUING WITHDRAWAL OF THE DEVICE, THE CATHETER SEPARATED OUTSIDE THE PATIENT. A SUBSEQUENT ATTEMPT TO REMOVE THE REMAINING SEGMENT RESULTED IN A SECOND EXTERNAL BREAK, AFTER WHICH THE REMAINING CATHETER WAS FULLY RETRIEVED. FLUOROSCOPIC IMAGING CONFIRMED NO RETAINED FRAGMENTS OR ARTERIAL DAMAGE. THE ACCESS SITE WAS CLOSED WITH A TR BAND. THE PATIENT REMAINED STABLE AND EXPERIENCED NO COMPLICATIONS. THE DEVICE WAS RETURNED AND RECEIVED BY THE MANUFACTURER, CONSISTING OF THREE CATHETER SEGMENTS WITH NO MISSING PORTIONS IDENTIFIED. FAILURE ANALYSIS OF THE REPORTED EVENT WAS PERFORMED. THE RETURNED ZEBRA 7F CATHETER FRACTURED IN TWO LOCATIONS, EXHIBITING CLEAR SIGNS OF STRETCHING ALONG MULTIPLE FRACTURE SITES AS A RESULT OF EXCESSIVE PULLING FORCE APPLIED DURING WITHDRAWAL AGAINST VESSEL RESISTANCE. THE INVESTIGATION DID NOT IDENTIFY ANY DESIGN, MATERIAL, OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE EVENT. THE OBSERVED FAILURE WAS MOST CONSISTENT WITH PROCEDURAL OR USE-RELATED FACTORS (E.G., RADIAL ARTERY VASOSPASM AND TRACTION DURING WITHDRAWAL) RATHER THAN A DEVICE DEFECT. BASED ON THE COMPLAINT DETAILS, PROCEDURAL CONTEXT, AND VISUAL FINDINGS, THE MOST PROBABLE CAUSE OF THE FRACTURE IS EXCESSIVE MECHANICAL FORCE OR TORQUING DURING ADVANCEMENT AGAINST RESISTANCE. THIS ALIGNS WITH THE ZEBRA CATHETER'S INSTRUCTIONS FOR USE (IFU), WHICH CAUTION THAT MANIPULATION OR TORQUING AGAINST RESISTANCE MAY RESULT IN DAMAGE TO THE VESSEL OR DEVICE.