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Manufacturing site: asahi intecc (thailand) co., ltd., pathum thani, thailand, registration number: (b)(4).When the reported product was returned to the manufacturer, reportable malfunction was recognized for the first time; therefore, g3.Date received by manufacturer is the same as the date in d9.Returned to manufacturer.The reported gaia pv18 guide wire was returned for investigation.The outer coil of the returned gaia pv18 guide wire was found elongated for approximately 700mm from the mid solder (set at 55mm from the wire tip to fix the outer coil onto the core wire).The core wire was found fractured at approximately 43mm distal to the mid solder.Microscopic observation of the proximal core wire fracture end found a flat fracture surface and helical marks on the shaft surface of the core wire, likely due to accumulated torsion.Microscopic observation of the distal segment of the outer coil found the ball tip at the very distal end of the outer coil.The outer coil was elongated from approximately 3.5mm proximal to the ball tip.The inner coil was exposed and its proximal end was fixed by solder, indicating that the inner coil was intact.The core wire was coming out of the solder and found fractured.The fracture end of the core wire was found with a flat fracture surface and helical marks on the shaft surface of the core wire, likely due to accumulated torsion.With the outer coil and the inner coil remained in one piece, measurement of the core wire (fractured at approximately 12mm from the wire tip) suggested that the entire guide wire was returned.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 the investigation outcome, it was presumed that torsion generated with guide wire manipulation might have been locally accumulated on the gaia pv18 guide wire while its distal segment had been caught by the cto lesion.Consequently, the core wire was fractured.The outer coil could eventually elongated during the subsequent withdrawal attempts.Although it was concluded that this event was not attributed to product quality, it was concluded that wire fragment would be inevitably left in situ should the same event recur.Capa: no capa will be taken.The instructions for use (ifu) states: [warnings] ~ observe guide wire movement in the vessels.Before a guide wire is moved or torqued, the tip movement should be examined and monitored under fluoroscopy.Do not move or torque a 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 guide wire and its location in the vessel are visible during wire manipulations.~ 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.[malfunctions and adverse events] ~ separation or breakage of the guide wire.
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It was reported that an endovascular treatment (evt) was performed for a mildly calcified and mildly tortuous chronic total occlusion (cto) in the anterior tibial artery (ata).After femoral puncture, an asahi gaia pv18 guide wire was advanced subintimal to the ata as the superficial femoral artery (sfa) had been chronically occluded and reconstructed somewhere between the popliteal artery and the tibioperoneal trunk.When an attempt was made to enter the gaia pv18 guide wire from the ata takeoff, the guide wire looked buckled and collapsed onto itself.During removal attempts, the tip of the guide wire began to unravel.With use of a trailblazer support catheter (medtronic), the gaia pv18 guide wire was removed ex situ without losing any part of it.The true lumen distal to the cto could not be accessed and revascularization could not be achieved.It was informed that the physician torqued the guide wire at a slow steady pace and was very familiar with the wire and algorithm.It was also informed that there was no health hazards caused to the patient due to the reported event.
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