Description of Event or Problem · 0
INITIAL EVENT AS REPORTED: IT WAS REPORTED THAT A MICROGUIDE 0.014 PORTAL, WAS BROKEN INSIDE A VASCO 10 MICROCATHETER AND BECAME AN INTRAVASCULAR FOREIGN BODY IN THE CEREBRAL ARTERIES. THE REASON FOR TREATMENT WAS CEREBRAL EMBOLIZATION. ADDITIONAL INFORMATION WAS RECEIVED ON 30-JUN-2025 AS REQUESTED BY THE MANUFACTURER: PRIOR TO THE PROCEDURE, THE ENTIRE GUIDEWIRE WAS SUFFICIENTLY HYDRATED IN PHYSIOLOGICAL SOLUTION IN ACCORDANCE WITH THE DEVICE'S INSTRUCTIONS FOR USE (IFU). THE TIP WAS SHAPED USING THE PROVIDED INSERTION TOOL BEFORE USE. NO DAMAGE, SUCH AS KINKS, WAS NOTED ON THE GUIDEWIRE BEFORE THE PROCEDURE. THE GUIDEWIRE WAS NOT REMOVED OR REINSERTED DURING THE PROCEDURE, AND THEREFORE WAS NOT RE-EXAMINED OR WIPED WITH GAUZE AT ANY POINT. THE USER DID NOT EXPERIENCE RESISTANCE DURING EITHER ADVANCEMENT OR RETRACTION OF THE GUIDEWIRE. THERE WAS NO ADVANCEMENT OR WITHDRAWAL AGAINST RESISTANCE WITHIN THE PATIENT'S ANATOMY, AND THE GUIDEWIRE WAS NOT EXCESSIVELY ROTATED DURING NAVIGATION. THE PROCEDURE WAS CONDUCTED UNDER CONTINUOUS FLUOROSCOPIC MONITORING. AN ANCILLARY DEVICE, A VASCO 10 MICROCATHETER (BALT), WAS USED IN CONJUNCTION WITH THE GUIDEWIRE. THIS MICROCATHETER WAS HYDRATED BEFORE USE, AND NO DAMAGE (E.G., KINKS) WAS NOTED BEFORE OR AFTER ITS USE. IT IS REPORTED THAT THE PATIENT HAS NO KNOWN PRE-EXISTING CONDITIONS OR MEDICAL HISTORY THAT WOULD HAVE CONTRIBUTED TO AN UNSUCCESSFUL DEVICE USE. THE GUIDEWIRE FRACTURED AT THE DISTAL END, AND INTERVENTION WAS REQUIRED TO RETRIEVE THE BROKEN FRAGMENT. A BALT CATCHVIEW STENT RETRIEVER WAS USED SUCCESSFULLY TO EXTRACT THE BROKEN PORTION OF THE GUIDEWIRE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A SYNCHRO MICROGUIDEWIRE, AND NO FURTHER COMPLICATIONS OCCURRED AFTER RETRIEVAL. IT IS REPORTED THAT THE PATIENT REMAINS STABLE FOLLOWING THE EVENT.