Description of Event or Problem · 1
"DURING AN AVM EMBOLIZATION PROCEDURE, A SYNCHRO GUIDEWIRE (BOSTON SCIENTIFIC) WAS USED FOR INITIAL ACCESS. DURING THE PROCEDURE THE DISTAL 10CM OF THE GUIDEWIRE HAD BROKEN OFF AND BECOME LODGED FROM THE ANTERIOR CEREBRAL ARTERY TO THE INTERNAL CAROTID ARTERY. MULTIPLE ATTEMPTS TO RETRIEVE THE BROKEN WIRE HAD BEEN MADE WITH THREE SEPARATE AMPLATZ GOOSE NECK MICROSNARES (EV3) WERE UNSUCCESSFUL. THE PHYSICIAN THEN USED THREE ALLIGATOR RETRIEVAL DEVICES, ARDS (CHESTNUT MEDICAL TECHNOLOGIES) TO ATTEMPT RETRIEVAL. ON THE FINAL ATTEMPT TO RETRIEVE THE GUIDEWIRE A 5MM ARD WAS USED. THE CAROTID VESSEL WAS IN SPASM AND THE DISTAL END OF THE ARD WAS NOT RETRACTING INTO THE MICROCATHETER. THE PHYSICIAN TORQUED THE DEVICE (DEVICE IS NOT INTENDED TO BE TORQUED). AFTER SEVERAL MINUTES OF MANIPULATION IT WAS OBSERVED THAT THE DEVICE COIL BEGAN TO "UNRAVEL" FROM ITS CORE-WIRE. THE PROCEDURE WAS THEN STOPPED AND THE ARD WAS LEFT IN PLACE. THE DETACHED GUIDEWIRE END WAS LATER REMOVED DURING THE SURGICAL AVM RESECTION. THE PT REMAINS ASYMPTOMATIC FROM THE INDWELLING ARD. THE PHYSICIAN NOTED THAT TORQUE HAD BEEN APPLIED TO THE ARD DURING USE AND THAT HE WAS NOT AWARE OF ANY WARNINGS AGAINST THIS. THE IFU-0002 ACCOMPANYING EACH ALLIGATOR RETRIEVAL DEVICE SOLD EXPLICITLY WARNS "DO NOT TORQUE DEVICE DURING USE". ALTHOUGH CHESTNUT MEDICAL PROVIDES SEVERAL METHODS OF COMMUNICATION TO MAKE THE USER AWARE OF THIS WARNING, A REMEDIAL ACTION IS NECESSARY. A NEW LABEL INSERT TO THE PACKAGING OF THE ARD USING BOTH SYMBOLS AND LANGUAGE WARNING "DO NOT ROTATE THE ARD DURING USE" IS TO BE ADDED TO EACH NEW PRODUCT UNTIL FURTHER PACKAGE CHANGES CAN BE MADE. THE INITIAL PACKAGING CHANGE UNDER CONSIDERATION IS TO REMOVE THE DEVICE HANDLE FROM THE DEVICE PACKAGING CONTENTS AND REPLACE IT WITH A WIRE RETENTION CLIP. THE MFR BELIEVES THAT THE DEVICE HANDLE, WHICH IS INTENDED FOR LATERAL MOVEMENT ONLY, MAY BE INCORRECTLY MISTAKEN AS A TORQUE HANDLE BY USERS THAT HAVE NOT READ THE IFU.