(b)(4).The customer returned one spring wire guide (swg) and a lidstock for evaluation.The guide wire was observed to be separated at the distal end; the distal weld was not returned.The distal end of the core wire appeared to be flattened and discolored.Microscopic examination confirmed the proximal weld was present; however, it was also slightly unraveled.The overall length of the core wire measured 602 mm which is within the specification of 596-604 mm per guide wire product drawing.This indicates that the entire core wire was returned.The outer diameter of an undamaged portion of the guide wire measured 0.791 mm which is within the specification of 0.788-0.826 mm per guide wire product drawing.The undamaged portions of the swg were advanced through a lab inventory 18ga introducer needle and lab inventory ars to functionally test the guide wire.The guide wire passed through with minimal resistance.A manual tug test confirmed that the proximal weld was intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit warns the user, "do not apply undue force on guidewire to minimize the risk of possible breakage." the customer report of a separated guide wire was confirmed by investigation of the returned sample.The guide wire was separated at the distal end of the guide wire.The sample passed dimensional inspection and a device history record review was performed with no relevant findings.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.This internal specification is higher than the bs en iso 11070:2014 standard of 2.2 pounds force for a guidewire of this size.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Based on these circumstances, unintentional use error (undue force) likely contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
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