(b)(4).The customer returned one spring wire guide (swg) within the advancer tubing and catheter for evaluation.No signs of use were present on either of the returned components.Visual examination of the returned swg confirmed the kink in the guide wire body.During normal assembly, the kink in the coil of the guide would have been located inside the guide wire cap, protecting it from damage.No damage was noted on the tube assembly.The distal j-bend was intact.Both welds appeared spherical and fully formed.The kink in the guide wire body was located at 565 mm from the proximal end.The total length of the guide wire measured to be 603 mm which is within specifications of 596-604 mm per swg product drawing.The outer diameter of the guide wire measured to be 0.802 mm which is within specifications of 0.788-0.826 mm per product drawing.The returned guide wire was advanced through the returned catheter and a lab inventory ars and 18 ga introducer needle to functionally test.The swg passed through all three with minimal resistance.A manual tug test confirmed both welds were fully intact on the guide wire.A device history record review was performed and no relevant findings were identified.The instructions for use (ifu) provided with the kit informs the user, "do not use if package is damaged." the report that the spring wire guide was found to be kinked prior to use was confirmed through visual examination of the returned sample.The returned guide wire had one kink in its body.The swg passed all relevant dimensional and functional inspection.A device history record review was performed with no relevant findings to suggest a manufacturing related cause.During normal packaging, the portion of the guide wire that kinked would have been located inside the guide wire cap, protecting it from damage.Therefore, it cannot be confirmed when the guide wire was kinked.The root cause of this investigation is undetermined.Teleflex will continue to monitor and trend for complaints of this nature.
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