TRUFILL PUSHABLE COILS

Description of Event or Problem

COIL KINKED. DURING A TRANS-ARTERIAL EMBOLIZATION (TAE) PROCEDURE WITHIN AN UNKNOWN TARGET LESION, THE FIFTH COIL KINKED AS IT WAS ADVANCED TOWARD THE TARGET LESION. THIS COIL WAS REMOVED WITHOUT DIFFICULTY. ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO INFORMATION WAS AVAILABLE WHICH MC WAS USED. CONTINUOUS FLUSH WAS MAINTAINED WITHIN THE MC.

Additional Manufacturer Narrative

THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING, HOWEVER, THE ENGINEERING EVALUATION IS NOT YET COMPLETE. PLEASE NOTE ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.