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BRAND NAMEGDC
TARGET THERAPEUTICS, INC.
47201 LAKEVIEW BLVD.
FREMONT CA 94538
ACCESS NUMBERM878983
PRODUCT CODEKRD
PANELCARDIOVASCULAR
REPORT TYPEMALFUNCTION
DATE FDA RECEIVED06/17/1996
DEVICE CATALOGUE NUMBER340515
EVENT DESCRIPTION TYPEFINAL
EVENT DESCRIPTION
"COIL #20 INSERTED, FRICTION, RETRIEVED AND WAS DETACHED PREMATURELY INSIDE THE CATHETER. NINETEEN #18 COILS DEPLOYED THROUGH THE SAME CATHETER. THE DEVICE WAS RETURNED AND AN ANALYSIS DONE TO DETERMINE THE CAUSE OF FAILURE. THE ANALYSIS FOUND THE PROXIMAL SECTION OF THE COIL IS STRETCHED. SEVERAL KINKS WERE FOUND THROUGH OUT THE COIL. THE COIL BROKE AT THE SOLDER JOINT, WHICH HAS BEEN PARTIALLY PULLED APART. FROM THE CONDITION OF THE DEVICE IT WOULD APPEAR THE DEVICE BECAME JAMMED INSIDE THE CATHETER AND WHILE ATTEMPTING TO REPOSITION THE COIL BROKE. NO EVIDENCE OF ATTEMPTS TO DETACH THE DEVICE WITH ELECTROLYSIS IS APPARENT ONTHE RETURNED PIECES. THE 0.002" WIRE, FROM WHICH COIL IS MADE, HAS A TENSILE STRENGTH OF 0.56 LBS. THE MOST PROBABLE CAUSE FOR THE FAILURE OF THE DEVICE COULD BE THE USE OF A FORCE IN EXCESS OF 0.6 LBS TO REPOSITION THE COIL AFTER THE DEVICE BECAME JAMMED INSIDE THE LUMEN OF THE CATHETER. THE PUSHER WIRE CONFORMS TO ALL SPECIFIED REQUIREMENTS WHICH AFFECT PROPER ALIGNMENT AND SUCCESSFUL FUNCITONAL PERFORMANCE OF THE UNIT. THE ISOLATED INCIDENT HAS BEEN DISCUSSED AT CO'S WEEKLY PRODUCT PERFORMANCE REVIEW BOARD MEETING WHICH RESULTED IN A HEIGHTENED AWARENESS BY THE NUMEROUS DEPTS.
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