(b)(4).The customer returned one guide wire for evaluation.The catheter was not returned.Visual examination revealed the guide wire contains three kinks with the guide wire body.The core wire was also observed to have broken adjacent to the proximal weld and the distal weld appeared full and spherical.The kinks measured at 220mm, 444mm and 475mm from the distal end.The overall length of the broken core wire measured 598mm which is within specification of 596-604mm per product drawing; therefore no pieces of the core wire appear to be missing.The outer diameter of the guide wire measured.794mm which is within specification of.788-.826mm per product drawing.The undamaged portions of the guide wire were able to pass through an ars connected to an introducer needle with minimal resistance.A manual tug test confirmed the distal weld was intact.A dhr review was completed with no relevant findings.The instructions-for-use (ifu) provided with this product describes suggested techniques to minimize the likelihood of guide wire damage during use.The ifu cautions that if resistance is encountered when attempting to remove the spring-wire guide after catheter placement, the spring-wire may be kinked about the tip of the catheter within the vessel which may result in undue force being applied resulting in spring wire guide breakage.If resistance is encountered, withdraw the catheter relative to the spring-wire guide about 2-3 cm and attempt to remove the spring-wire guide.If resistance is again encountered, remove the spring-wire guide and catheter simultaneously.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.Dimensional inspection 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 use error likely contributed to this event, however, the probable cause of guide wire and catheter resistance could not be determined based upon the information provided and without the catheter being returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.
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