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Patient 1
(B)(4). THE GUIDE WIRE AND ITS FRAGMENT WERE RETURNED FOR EVALUATION. THE DISTAL SEGMENT OF THE RETURNED GUIDE WIRE WAS DEFORMED INTO A LOOP AT APPROXIMATELY 130 MM FROM THE SOLDER SET AT 300 MM PROXIMAL TO THE TIP. AT APPROXIMATELY 160 MM DISTAL TO THE SOLDER, THE CORE WIRE WAS FOUND FRACTURED. AT APPROXIMATELY 12 MM DISTAL TO THE CORE FRACTURE END, THE COIL WIRE WAS FOUND FRACTURED. THE FRACTURE END OF THE CORE WIRE WAS FLAT, SUGGESTING TORSION WAS GENERATED AS THE COILS GOT STRAIGHTENED. THE CORE FRACTURE WAS MICROSCOPICALLY OBSERVED. IT FOUND THAT THE CORE WIRE WAS SHARPLY BENT AND DEMONSTRATED A FLAT FRACTURE SURFACE. OBSERVATION BY A SCANNING ELECTRON MICROSCOPE (SEM) REVEALED A TRACE OF FRACTURE BY BENDING AND TORSIONAL STRESS. THE RETURNED WIRE FRAGMENT WAS UNDULATED. IT WAS BENT IN A U-SHAPE AT THE PROXIMAL END. THE COILS WERE STRETCHED FOR APPROXIMATELY 25 MM AND THEN FRACTURED. AS SEEN ON THE PROXIMAL SIDE OF COIL FRACTURE, THE FRACTURE END WAS FLAT; IT SUGGESTED THAT COIL WIRE BECAME FRACTURED BY TORSION GENERATED AS COILS GOT STRAIGHTENED. TO OBSERVE THE CORE UNDERNEATH, COILS WERE INTENTIONALLY UNRAVELED. THE CORE WAS FOUND FRACTURED AT APPROXIMATELY 140 MM FROM THE WIRE TIP. SEM OBSERVATION REVEALED A TRACE OF FRACTURE BY BENDING AND TORSIONAL STRESS, AS SEEN ON THE PROXIMAL SIDE OF FRACTURE. BY MEASURING THE CORE LENGTH OF THE RETURNED WIRE AND ITS FRAGMENT, IT WAS CONCLUDED THAT THE ENTIRE WIRE WAS RETURNED. 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 BENDING STRESS WITH TORSION THAT EXCEEDED THE PRODUCT'S DESIGN LIMIT WAS INADVERTENTLY APPLIED AS THE WIRE WAS ASSUMED TO BE PROLAPSED BY WIRE MANIPULATION THAT MIGHT BE AFFECTED BY VESSEL CONDITION, CAUSING THE CORE TO BECOME FRACTURED. THE COILS WERE ASSUMED TO BE STRETCHED AND EVENTUALLY SEPARATED UPON WIRE REMOVAL. THERE WAS NO INDICATION OF PRODUCT DEFICIENCY. INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS] NEVER PUSH, AUGER, WITHDRAW, OR TORQUE A GUIDEWIRE THAT MEETS THE RESISTANCE. TORQUING OR PUSHING A GUIDEWIRE AGAINST RESISTANCE MAY CAUSE GUIDEWIRE DAMAGE AND/OR GUIDEWIRE TIP SEPARATION OR DIRECT DAMAGE TO A VESSEL. RESISTANCE MAY BE FELT AND/OR OBSERVED UNDER FLUOROSCOPY BY NOTING ANY BUCKING OF THE GUIDEWIRE TIP. IF GUIDEWIRE TIP PROLAPSE IS OBSERVED, DO NOT ALLOW THE TIP TO REMAIN IN A PROLAPSED POSITION; OTHERWISE DAMAGE TO THE GUIDEWIRE MAY OCCUR. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE ANY NECESSARY REMEDIAL ACTION; AND, [MALFUNCTION AND ADVERSE EFFECTS] BREAKAGE OR BENDING OF THE GUIDE WIRE.