Qn# (b)(4).The customer returned one guide wire for analysis.The introducer needle was not returned.No definite signs-of-use were observed.The major kinks in the guide wire measured 128mm, 255mm, and 275mm ruler: (b)(4) from the distal weld.A manual tug test confirmed the distal weld was secure and intact.The total length of the returned core wire measured to be 602mm ruler: (b)(4) which is within specification.The undamaged portion of the swg passed through the lab inventory introducer needle/ars subassembly with minimal resistance.The report that the guide wire was unraveled was confirmed through examination of the returned sample.The guide wire core wire was broken adjacent to the proximal weld.The guide wire met all relevant dimensional and functional requirements, and a device history record review did not reveal any evidence of a manufacturing related issue.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 this size wire.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 user error likely contributed to this event; however, the probable cause of guide wire/needle resistance could not be determined based upon the information provided and without the needle being returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.
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