UNKNOWN TRUFILL PUSHABLE COIL

Description of Event or Problem

DURING A COIL EMBOLIZATION OF AN UNKNOWN TARGET SITE WHEN THE TRUFILL COIL (UNKNOWN PRODUCT CODE) WAS ADVANCED USING THE TRUFILL COIL PUSHER THE COIL WAS STUCK AND STOPPED ADVANCING THROUGH THE UNKNOWN MICROCATHETER. THE SYSTEM WAS REMOVED AND CHANGED TO OTHER PRODUCTS. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT INJURY. THERE WERE NO CONTRIBUTING ISSUES NOTED WITH THE COIL PUSHER OR THE MICROCATHETER. THE MICROCATHETER WAS FLUSHED AFTER EVERY COIL WAS DELIVERED. NO ADDITIONAL INFORMATION IS KNOWN.

Additional Manufacturer Narrative

THE DEVICES ARE NOT AVAILABLE FOR ANALYSIS AND THE LOT NUMBER OF THE TRUFILL COIL IS NOT KNOWN; THEREFORE A DEVICE HISTORY RECORD IS NOT POSSIBLE. PROCEDURAL FACTORS THAT MAY HAVE IMPACTED THE EVENT INCLUDE VESSEL/LESION CHARACTERISTICS, INADEQUATE CONTINUOUS FLUSH THROUGH THE MICROCATHETER, AND DEVICE INTERACTION. BASED ON THE LACK OF CLINICAL INFORMATION AND WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, NO CONCLUSION CAN BE MADE REGARDING THE TRUFILL BECOMING IMPEDED IN THE UNKNOWN MICROCATHETER WHEN ADVANCED WITH THE TRUFILL COIL PUSHER. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. PLEASE NOTE: THE CATALOG AND LOT NUMBER/(S) FOR THE ACTUAL PRODUCT/(S) USED IN THE PROCEDURE ARE UNKNOWN. AN INVESTIGATION IS IN PROCESS TO RETRIEVE THIS INFORMATION.