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Patient 1
(B)(4). THE GLADIUS MG14 PV MISSING ITS TIP WAS RETURNED FOR EVALUATION. THE DISTAL SEGMENT OF THE RETURNED GUIDE WIRE WAS THREE-DIMENSIONALLY DEFORMED. THE POLYMER JACKET AND THE COIL WIRE WERE FRACTURED AT THE SAME LOCATION, EXPOSING THE FRACTURED CORE WIRE. FOR OBSERVATION PURPOSES, THE POLYMER JACKET WAS REMOVED. THE FRACTURE END OF THE CORE WIRE WAS LOCATED AT APPROXIMATELY 20MM DISTAL TO THE MID SOLDER THAT WAS ORIGINALLY LOCATED AT 27MM FROM THE TIP. THE FRACTURED END OF THE COIL WIRE WAS LOCATED AT APPROXIMATELY 15MM DISTAL TO THE MID SOLDER. OBSERVATION BY SCANNING ELECTRON MICROSCOPE WAS PERFORMED ON THE FRACTURE END. IT REVEALED THAT THERE WERE CIRCUMFERENTIAL CRACKS ON THE CORE WIRE SHAFT PROXIMAL TO ITS FRACTURE END, INDICATING REPEATED BENDING STRESS HAD APPLIED ON THE CORE WIRE. THE CORE FRACTURE END WAS SMALLER THAN THE ORIGINAL SIZE OF THE CORE, SUGGESTING TENSILE STRESS HAD ALSO APPLIED ON THE CORE WIRE. THE FRACTURE END OF THE COIL WIRE SHOWED A FLAT FRACTURE SURFACE, ONE OF CHARACTERISTICS FOUND ON FRACTURE BY TORSION THAT HAD LIKELY GENERATED AS COILS WERE BEING PULLED AND STRAIGHTENED. ABOVE FINDINGS SUPPORTED THAT THE REPORTED GUIDE WIRE WAS MISSING APPROXIMATELY 7MM OF THE CORE WIRE AND APPROXIMATELY 15MM OF COILS WITH UNDERLYING INNER COILS. 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 PRESUMED THAT REPEATED BENDING STRESS HAD MOST LIKELY CONTRIBUTED TO THE OBSERVED FRACTURE OF THE CORE WIRE. THE ACCUMULATED BENDING STRESS WOULD EXCEED THE PRODUCT DESIGN LIMIT WHEN THE GUIDE WIRE WAS BEING TRAPPED AND ITS MOVEMENT WAS RESTRICTED BY THE LESION. FURTHER APPLIED TENSILE STRESS GENERATED WITH REMOVAL HAD CAUSED THE COIL WIRE TO BE PULLED APART WITH THE INNER COIL WIRE. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS] OBSERVE MOVEMENT OF THIS GUIDE WIRE IN THE VESSELS. BEFORE THIS GUIDE WIRE IS MOVED OR TORQUED, THE TIP MOVEMENT SHOULD BE EXAMINED AND MONITORED UNDER FLUOROSCOPY. DO NOT MOVE OR TORQUE THE GUIDE WIRE WITHOUT OBSERVING CORRESPONDING MOVEMENT OF THE TIP. IN ADDITION, ENSURE THAT THE DISTAL TIP OF THIS GUIDE WIRE AND ITS LOCATION IN THE VESSEL ARE VISIBLE DURING MANIPULATIONS OF THE GUIDE WIRE; [WARNINGS] NEVER PUSH, AUGER, WITHDRAW, OR TORQUE A GUIDE WIRE THAT MEETS RESISTANCE. TORQUING OR PUSHING A GUIDE WIRE AGAINST RESISTANCE MAY CAUSE GUIDE WIRE DAMAGE AND/OR GUIDE WIRE TIP SEPARATION OR DIRECT DAMAGE TO A VESSEL. RESISTANCE MAY BE FELT AND/OR OBSERVED UNDER FLUOROSCOPY BY NOTING ANY BUCKLING OF THE GUIDE WIRE TIP. IF GUIDE WIRE TIP PROLAPSE IS OBSERVED, DO NOT ALLOW THE TIP TO REMAIN IN A PROLAPSED POSITION.[OTHERWISE DAMAGE TO THE GUIDE WIRE MAY OCCUR.] DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE ANY NECESSARY REMEDIAL ACTION; [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; AND, [MALFUNCTION AND ADVERSE EFFECTS] SEPARATION OF THE GUIDE WIRE.