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Manufacturing site: asahi intecc (thailand) co., ltd., pathum thani, thailand, registration number: 3003780911.The reported sion black guide wire was returned for evaluation with the tip fragment missing.From approximately 5mm distal to the distal mid solder (set at 25mm from the tip for the purpose of fixing the outer coil onto the core wire), polymer jacket of the returned sion black guide wire was found stretched for approximately 5mm and then torn off.The core wire was fractured at approximately 17mm distal to the distal mid solder.Originating from approximately 5mm from the distal mid solder, the outer coil was found stretched for 14mm and then fractured.The twist wire was found fractured at approximately 22mm distal to the distal mid solder.Microscopic observation of the inner coil found that the coil was disarranged.Observation by scanning electron microscope (sem) found that each fracture end of the core wire, outer coil and twist wire was necked due to tensile stress.Investigation of the returned guide wire suggested that the core wire was fractured at approximately 8mm from the tip, the twist wire was fractured at approximately 3mm from the tip, the outer coil was fractured at approximately 19mm from the tip, and the polymer jacket was torn off at approximately 20mm from the tip.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 tensile stress and torsion generated with wire removal might have been locally applied on the tip of the sion black guide wire while the guide wire had been trapped by the deployed stent.Consequently, the guide wire was fractured.Although it was concluded that this event was not attributed to product quality, wire fragment remained in patient anatomy was considered an adverse effect.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.Do not perform stent placement using more than one guide wire or wire operation through stent strut.Otherwise, the stent may be damaged or the guide wire may break or break apart.[malfunction and adverse effects]: separation of the guide wire.
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It was reported that the tip of an asahi sion black guide wire had separated during a percutaneous peripheral intervention (ppi) to treat the mildly tortuous, moderately calcified superficial femoral artery (sfa).The sion black guide wire was advanced to cross an occluded stent in the sfa and was delivered to the target segment through the stent strut.An unspecified balloon was able to be inflated.Upon removal of the sion black guide wire, the wire tip appeared to have sheared off.The wire fragment remained in the patient anatomy and the physician determined to follow-up monitor the patient.The patient was discharged and sent home after a few hours of bedrest.The physician commented that it was speculated earlier in the case that the guide wire may have been advanced through a stent strut because resistance was felt during advancement of the concomitant catheter.It was informed that the patient was fine without any issues after the procedure.
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