VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE

Description of Event or Problem

IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED FOLLOWING THE OCCURRENCE OF A VASCULAR PERFORATION. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE WAS SELECTED FOR USE. WHILE ADVANCING THE SYSTEM, THE DILATOR PULLED BACK UNEXPECTEDLY, RESULTING IN DISPLACEMENT OF THE WIRE AND SUBSEQUENT PERFORATION. THE PHYSICIAN REPORTED THAT THE DEVICE AND/OR PROCEDURAL INTERACTION CONTRIBUTED TO THE EVENT, NOTING THAT THE DILATOR WAS LOOSE AT THE TIME. A BALLOON WAS PLACED IN THE LEFT ILIAC VEIN AS PART OF THE INTERVENTION. THE PROCEDURE WAS UNSUCCESSFUL DUE TO THE PERFORATION. THE PATIENT WAS NOT ADMITTED BEYOND THE STANDARD OF CARE AND IS EXPECTED TO FULLY RECOVER. FURTHER INFORMATION WAS RECEIVED INDICATING THAT THE DILATOR WAS LOOSE, MEANING THE DILATOR WAS NOT PROPERLY SNAPPED INTO OR SECURED WITH THE SHEATH, RESULTING IN INADEQUATE FIXATION BETWEEN COMPONENTS. THE RF WIRE WAS EXPOSED OUTSIDE OF THE VERSACROSS DILATOR AT THE TIME THE PERFORATION OCCURRED, ALTHOUGH NO RESISTANCE WAS FELT WHILE MANEUVERING THE CATHETER; RESISTANCE WAS ONLY NOTED WITH THE WIRE PRIOR TO ATTEMPTING TRANSSEPTAL ACCESS. NO GUIDEWIRE WAS USED DURING THE PROCEDURE. DURING THE PROCEDURE, BEFORE ANY TRANSSEPTAL PUNCTURE AND PRIOR TO THE INITIATION OF ABLATION, A VASCULAR COMPLICATION WAS IDENTIFIED INVOLVING A PERFORATION IN THE LEFT ILIAC VEIN, AT A TIME WHEN NO CATHETER WAS INSIDE THE PATIENT. NO ABLATION HAD TAKEN PLACE WHEN THE COMPLICATION WAS OBSERVED. A VASCULAR SURGEON WAS CALLED, AND THE PERFORATION WAS DETERMINED TO BE CONTAINED; HOWEVER, NO IMAGING WAS AVAILABLE TO CONFIRM THE EXACT PERFORATION SITE BEYOND THE LEFT ILIAC VEIN. IT WAS INFORMED THAT EFFUSION/TAMPONADE DISCOVERED DURING PROCEDURE. THE PATIENT WAS EXPECTED TO RECOVER, THOUGH ADDITIONAL DETAILS REGARDING THEIR CURRENT CONDITION OR WHETHER HOSPITALIZATION WAS EXTENDED ARE UNKNOWN. FURTHER INFORMATION LATER CLARIFIED THAT THE DILATOR BECAME UNSNAPPED AS IT WAS PULLED BACK UNEXPECTEDLY, RATHER THAN BEING LOOSE BEFOREHAND. THE RF WIRE WAS BEING ADVANCED TOGETHER WITH THE DILATOR AND SHEATH, THOUGH THE EXACT LENGTH OF WIRE EXTENDING BEYOND THE DILATOR TIP AT THE TIME OF THE EVENT IS UNKNOWN. THE PERFORATION OCCURRED NEAR THE LEFT ILIAC VEIN, CONFIRMING THAT THE SYSTEM HAD NOT YET REACHED THE HEART OR SVC. FOLLOWING THE INCIDENT, NO DAMAGE WAS OBSERVED ON EITHER THE RF WIRE OR THE DILATOR. THE EVENT INVOLVED ONLY AN ILIAC VEIN PERFORATION, WITH NO PERICARDIAL EFFUSION OR CARDIAC TAMPONADE REPORTED. THE PATIENT WAS HOSPITALIZED AFTER THE EVENT; HOWEVER, INFORMATION REGARDING MEDICATIONS ADMINISTERED, DISCHARGE STATUS, OR THE PATIENT'S CURRENT CONDITION WAS NOT AVAILABLE FROM THE ACCOUNT/CUSTOMER.