(b)(4).Single reporter exemption #e2015028.The importer report number used for this report was generated from the importer registration number, current year, and sequential number that match the manufacturer report number.The guide wire was returned for evaluation.The distal segment of the returned guide wire was helically deformed originating approximately 130mm distal to the proximal solder.Elongation of the coil wire and the polymer jacket was observed on the deformed segment.The core wire was exposed and found fractured at approximately 155mm distal to the proximal solder.Microscopic observation of the fracture ends revealed that the core wire was necked.This indicated the core wire fracture was due to tensile stress.The coil wire had a flat fracture surface that suggested twisting stress was generated as coils got straightened.Lot history review revealed no anomaly relating to the reported event.No other similar product experience report was received from this lot.Reviewing of production records found no indication of product deficiency.It was concluded that tensile stress exceeding the product's design limit was inadvertently applied while the wire was being trapped possibly by the lesion.That excess stress was assumed to have contributed to the reported wire breakage.Although it was reported there were no adverse patient effects, the separated segment was not returned and damage of the polymer jacket was severe; therefore, it was concluded that a possibility that some fragments might be left in the anatomy could not be completely ruled out.Instructions for use (ifu) states: [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 or breakage of the guide wire.
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