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Patient 1
(B)(4). WHEN THE GUIDE WIRE WAS RETURNED TO THE MANUFACTURER, A REPORTABLE MALFUNCTION (CORE WIRE FRACTURE) WAS RECOGNIZED FOR THE FIRST TIME; THEREFORE, THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT WAS CONSIDERED THE DATE THE DEVICE RETURNED. COILS OF THE RETURNED GUIDE WIRE WERE STRETCHED FOR APPROXIMATELY 35 MM PROXIMAL TO THE MIDDLE SOLDER SET TO BE AT 40 MM FROM THE WIRE TIP. UNDER THE STRETCHED COILS, THE INNER COIL WIRE WAS EXPOSED AND FOUND FRACTURED AT APPROXIMATELY 10 MM PROXIMAL THE SOLDER. THE PROXIMAL END OF THE INNER COIL WIRE WAS SOLDERED; THE INNER COIL WIRE REMAINED IN ONE PIECE. THE DISTAL SOLDER WAS FOUND AT THE END OF THE STRETCHED COIL WIRE; THE COIL WIRE WAS ALSO REMAINED IN ONE PIECE. MEASURING THE LENGTH OF THE CORE WIRE, IT WAS CONCLUDED THAT THE ENTIRE GUIDE WIRE WAS RETURNED. SEM WAS USED TO OBSERVE THE FRACTURE SURFACE OF THE CORE WIRE. THE FRACTURE SURFACE WAS RELATIVELY FLAT AND DEMONSTRATED CIRCULAR PATTERN WITH DIMPLES. THESE FINDINGS SUGGESTED THAT THE CORE WIRE BECAME FRACTURED DUE TO TORSION. TO OBSERVE THE DISTAL SIDE OF THE CORE FRACTURE SURFACE, THE COIL WIRE AND THE INNER COIL WIRE WERE REMOVED. THE CORE WIRE WAS FOUND FRACTURED AT APPROXIMATELY 13 MM FROM THE TIP. SEM WAS ALSO USED TO OBSERVE THE FRACTURE SURFACE OF THE CORE WIRE. THE DISTAL FRACTURE SURFACE SHOWED THE SAME CHARACTERISTICS OBSERVED ON THE PROXIMAL FRACTURE SURFACE. LOT HISTORY REVIEW REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT. NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED FOR THIS LOT. BASED ON THE OBTAINED INFORMATION AND INVESTIGATION OUTCOME, IT WAS CONCLUDED THAT TORSION EXCEEDING THE PRODUCT'S DESIGN LIMIT WAS INADVERTENTLY APPLIED WHEN THE WIRE MOVEMENT WAS RESTRICTED POSSIBLY BY TORTUOUS VESSEL, LEADING THE CORE WIRE TO BECOME FRACTURED. THE COIL WIRE WAS ASSUMED TO BE STRETCHED BY PULLING STRESS GENERATED ALONG WIRE REMOVAL. THERE WAS NO INDICATION OF PRODUCT DEFICIENCY. INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS] IF ANY RESISTANCE IS FELT DUE TO SPASM OR THE GUIDEWIRE BEING BENT OR TRAPPED WHILE OPERATING THE GUIDEWIRE IN THE BLOOD VESSEL OR REMOVING IT, DO NOT MOVE OR TORQUE THE GUIDEWIRE. STOP THE PROCEDURE. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE APPROPRIATE REMEDIAL ACTION. IF THE GUIDEWIRE IS MOVED EXCESSIVELY, IT MAY BREAK OR BECOME DAMAGED, WHICH MAY CAUSE BLOOD VESSEL INJURY OR RESULT IN FRAGMENTS BEING LEFT INSIDE THE VESSEL; [WARNINGS] WHEN TORQUING THE GUIDEWIRE INSIDE THE BLOOD VESSEL, DO NOT TORQUE CONTINUOUSLY IN THE SAME DIRECTION. THIS MAY CAUSE THE GUIDEWIRE TO BECOME DAMAGED OR BREAK APART, CAUSING INJURY TO THE BLOOD VESSEL OR LEAVING FRAGMENTS INSIDE THE VESSEL. WHEN TORQUING THE GUIDEWIRE, ROTATE IT CLOCKWISE AND COUNTERCLOCKWISE ALTERNATELY. DO NOT EXCEED TWO ROTATIONS (720 DEGREES) IN THE SAME DIRECTION; AND, [MALFUNCTION AND ADVERSE EFFECTS] SEPARATION OR BREAKAGE OF THE GUIDE WIRE.