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Manufacturing site: (b)(4).The reported confianza pro 12 guide wire was returned for evaluation with concomitant non-asahi guide catheter and asahi caravel microcatheter.Tip separation was confirmed on the returned confianza pro 12.The core wire was found fracture at approximately 180mm from the proximal solder that was originally set at 193mm from the tip.The fractured coil wire was elongated for approximately 155mm from the proximal solder.Each fracture end was observed under the microscope.It revealed that the core wire had a flat fracture surface and helical marks were on the shaft, indicating torsion had contributed to fracture.The fractured end of the coil wire was necked, indicating tensile stress had contributed to fracture.Neither the guide catheter nor the microcatheter had damage that could contribute to the observed fracture of the guide wire.Lot history review revealed no anomaly relating to the reported event.No other similar product experience report was received from this lot.Based on the obtained information and investigation outcome, it was presumed that torsion generated with wire manipulation in attempts to cross the cto had most likely contributed to observed tip separation of the returned confianza pro 12 guide wire.The applied stress would localize and therefore exceed the product design limit when the tip was being caught and restricted its movement in the lesion.Further applied tensile stress generated with removal made the coil wire elongate and eventually fracture.It was concluded that this event was not attributed to product quality.No capa will be taken.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; otherwise, the guide wire may be damaged and/or trauma may occur.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.Never push, auger, withdraw, or torque this guide wire that meets resistance.Torquing or pushing this guide wire against resistance may cause damage and/or tip separation of this guide wire or direct damage to a vessel.Resistance may be felt and/or observed under fluoroscopy by noting any buckling of the guide wire.If the prolapse of the guide wire tip 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.If resistance is felt due to spasm, bending of the guide wire, or due to trap while operating this guide wire in the blood vessel or removing it, do not torque and/or pull the guide wire itself.Stop the procedure.Determine the cause of resistance under fluoroscopy and take appropriate remedial action.If the guide wire is moved excessively, it may break or become damaged, which may cause blood vessel injury or result in fragments being left inside the vessel.When torquing this guide wire inside the blood vessel, do not torque continuously in the same direction.This may cause the guide wire to become damaged or break apart, causing injury to the blood vessel or leaving fragments inside the vessel.When torquing the guide wire, rotate it clockwise and counterclockwise alternately.Do not exceed two rotations (720 degrees) in the same direction.[malfunction and adverse effects] separation of the guide wire.
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